Subjects were studied using a standard ventilator with settings matched as closely as possible with those on the subject’s own ventilator. These settings are termed the usual condition. Next, ventilator adjustments were made (with one-way valves removed), including the following: (1) lengthening inspiratory time (Ti), (2) applying positive end-expiratory pressure (PEEP), and (3) combining lengthened Ti and PEEP.

Lengthened Ti can improve speech produced during the inspiratory phase of the ventilator cycle. With lengthened Ti, air flows through the larynx longer so that Pt remains above the voicing threshold longer during inspiration Kamagra shop. Also, the flow is lower so that the rate of rise of Pt is reduced.

When speaking during usual expiration, nearly all the air in the lungs flows toward the ventilator because the ventilator pathway offers much lower impedance (ie, primarily resistance) to flow than does the laryngeal pathway . PEEP impedes expiratory flow and adds a threshold occlusion pressure to the ventilator expiratory line so that more air flows through the larynx than toward the ventilator . Thus, Pt stays above the voicing threshold longer during expiration than without PEEP (as long as the impedance offered by the larynx is adequately high, the usual case during speech production). A one-way valve shunts all expired air through the larynx by occluding the ventilator line.

In an attempt to elucidate the effects of corticosteroids on extracellular matrix gene expression, we studied the expression of fibronectin in fibroblasts treated Sildenafil online with FP. Fibronectin is an extracellular matrix glycoprotein that is highly expressed in acute and chronic forms of lung injury including COPD, asthma, and many interstitial lung diseases. Villiger et al demonstrated an increase in the production of fibronectin in alveolar macrophages obtained from smokers when compared to nonsmokers. Alveolar macrophages from patients with chronic bronchitis spontaneously released greater amounts of fibronec-tin than those from asthmatic patients and control subjects. The levels of fibronectin have been correlated with a decrease in pulmonary function in smokers with COPD. In asthma, airway wall remodeling is not only associated with increased deposition of extracellular matrices, but also with alterations in the composition of the airway wall connective tissue with increased deposition of fibronectin. The aforementioned studies have implicated excessive production of fibronectin as a marker of activation of tissue remodeling and a potential mechanism for promoting fibroproliferation in tobacco-related lung disease.

The pathophysiology of ED in men with diabetes mellitus (DM) is complex and multifactorial. Men with DM, even those without significant comorbidities, suffer from a wide range of sexual dysfunction Viagra in Australia online, including decreased desire and sexual satisfaction. Prevalence of ED among diabetic men that has been reported in the literature ranges widely. Unfortunately, many studies either have not differentiated between DM Type 1 and Type 2, or were not done in Type 1 diabetics. The prevalence of ED among men with DM in the MMAS was reported at three times the general population, or 28% versus 9.6%. A more recent study evaluated self-reported ED in males with DM Type 1 and found a prevalence of 20% overall and 47.1% in those 43 years of age or older. Along with objective factors, such as decreased libido, men with DM Type 2 demonstrate organic causes with a decreased nocturnal penile tumescence.

Several cellular and molecular derangements have been described in diabetic men that contribute to the increased risk of ED in this population. Vascular injury is an important cause of ED in this population. At gross anatomical level, men with diabetes have an increased prevalence of cavernosal arterial insufficiency, thus impaired arterial response, on ultrasound. An early study reported impaired endothelial-mediated vasodilation upon exposure to acetylcholine, a parasympathetic agent, in cavernosal tissue of diabetic men with ED. Since this study, endothelial dysfunction in cavernosal tissue of diabetic men has been characterized by abnormalities including, but not limited to, increased apoptosis, oxidative stress, and overactivity of protein kinase C. Thus, the effect of DM on penile vasculature is mechanically similar to its effect on other vascular structures throughout the body. Although advanced glycation end-products have been demonstrated in cavernosal tissue, their significance remains unclear. While a majority of research has focused on diabetic ED as vascular phenomenon, there is at least correlational evidence that autonomic neuropathy plays a role in the development of ED in diabetics. The existence of ED in men with diabetes is also predicted by age and other complications of diabetes, such as retinopathy and depression.

A large national epidemiologic study was able to review a very large database of the diabetic male population through the use of managed care claims. The study used this database to determine the prevalence of diabetes in men with and without ED. The prevalence of diabetes in men with ED was found to be much higher than the general population. Twenty percent of men suffering from ED were also found to have been diagnosed with diabetes; this is in comparison to only 7.5% in men without ED. Given this finding that men with ED are twice as likely to have diabetes as those without ED, the diagnosis of ED may indeed serve as a useable marker for diabetic screening. A similarly large national study in 2005 evaluating men with ED found four specific comorbidities to be significantly prevalent among men carrying the diagnosis of ED. The authors even suggested that ED may be used as an observable marker for all four: hypertension, hyperlipidemia, depression, and diabetes.

Treatment of ED in Diabetics

Although treatment of ED is discussed later in the book, it is prudent to mention here that certain trials in the past decade have been specifically dedicated to the treatment of ED in diabetic males. A retrospective analysis of data from twelve placebo-controlled trials evaluated the efficacy and safety of tadalafil for the treatment of ED in diabetic males. They confirmed that diabetic men have more severe ED than controls at baseline. Interestingly, they also found that baseline erectile function in the diabetic males correlated inversely with baseline HbA(1)c levels. They concluded that although ED was found to be more severe in the diabetic population, response to tadalafil was only slightly lower than controls for the treatment of ED.

Hypogonadism has been shown to reduce the frequency of sexual thoughts and inter-course. Low testosterone levels also decrease the frequency, volume, and quality of ejaculation. The effect of testosterone on different aspects of erectile function has been studied, and the current belief is that nocturnal penile tumescence and spontaneous erections are androgen-dependent. Audiovisual erotic stimulation predominantly causes erections through androgen-insensitive pathways, but some androgen sensitivity is likely. Rapid-eye-movement sleep has been shown to be reduced in hypogonadism, and although androgen reduction adversely affects sleep-related erections, it did not elimi-nate them over a 12-wk trial in healthy young adult men.

There are data for supranormal levels of testosterone from the exogenous administration of testosterone to normal males. The patterns of sexual intercourse, masturbation, and sexual interest were not found to change significantly. The information in this area has previously suggested compart-mentalization, with various functional aspects having different androgen sensitivities; the issue is unresolved but the sensitivities appear to overlap. The prospect that selective androgen modulation may be therapeutically harnessed remains a possibility. Certain types of age-related changes are associated with the length of the AR gene CAG repeat. CAG repeat lengths may play a role in setting different thresholds for the various androgen actions.

For example, Cheap Viagra Australia and Cialis are not aphrodisiacs. They do not increase one’s desire for sex; they augment erectile activity and usually require stimulation—physical and psychic—to be effective. Testosterone, on the other hand, acts on the libido without significantly increasing erectile response. Thus, if a healthy man has erectile dysfunction and a normal testosterone level, there is no reason to give him exogenous testosterone for the erectile dysfunction. In a double-blind, placebocontrolled crossover study, Raul Schiavi and colleagues reported that there was no effect on erectile functioning when testosterone was administered to men with erectile dysfunction. Only a slight increase in ejaculatory frequency was noted, and this was not connected with the participants’ self-reports of any increased sense of sexual desire.
The question of medication use by the healthy to enhance sexual function most often arises in connection with the process of healthy aging. The normal aging decrements in function versus the limitations caused by a disease process is a complicated and controversial subject. For an approach to this question, I look at the question of the aging body and sex.

THE AGING BODY AND SEX

From the perspective of a healthy, albeit aging, body, the ability for sexual activity resembles that for any other physical activity. In this view, sexual functioning is similar to jogging, swimming, hiking, and climbing stairs: the more one has done this in the past, the better one is able to do it now and in the future. There may be a general decline in motivation, speed, and endurance, but if essential health is a quality of the aging body, the ability to perform physical activities will remain essentially intact. In the sexual realm, at least for healthy men, a parallel decline in the sensory/neural and autonomic functioning of the genitals is part of the aging process. Erections are slower to attain, briefer in duration; seminal ejaculate is less; and orgasmic pleasure is satisfying but less intense than in earlier years.

Will a healthy older person be able to function sexually? The simple answer is, “The past is prologue,” as research studies on sex and aging have taught us. At least for elderly married men, past patterns of sexual activity are strong indicators of sexual vitality in older age. The more complex answer is, “It depends.” Whether or not an older person is interested in sex and is sexually active depends on a number of factors other than physical health. Availability of a partner, quality of the relationship, history of sexual expression (or lack thereof), competing interests or commitments (e.g., chosen celibacy) are some of the factors that predict sexual activity in an aging person. These factors are best understood in the life story and behavior perspectives, and I return to examine them in later chapters.

Cialis Australia Over The Counter – Cheap Erectile Dysfunction Drugs Online

One carefully designed study captures many of the issues involved in sex and healthy aging in men. Raul Schiavi, at the time a psychia trist and sex researcher at Mt. Sinai School of Medicine in New York City, recruited a sample of men (ages 45 to 75) carefully screened to minimize the effects of disease or medications as confounding factors in sexual functioning. Seventy-two heterosexual couples were interviewed, the spouses separately, about their sexual lives together. The men participated in nocturnal penile tumescence (NPT) sleep studies in which erectile tumescence (erection) was monitored with strain gauges attached to the penis. Much to the surprise of the investigators, a high proportion of the men above 65 who failed to have full erections during sleep were, by their own and their partner’s independent reports, able to have intercourse regularly and were quite satisfied with their sexual lives.

The strong suggestion in this finding is that compromised physiological status (abnormal NPT) can be overridden by the physical and emotional stimulation of a spouse. The relationship of sex and aging is a complex phenomenon, not given to simple single-cause explanations. While disease processes and “normal” decrements in function are factors to be reckoned with, in real life, many factors enter into the picture. Other perspectives, especially the life story perspective, with its emphasis on value and meaning, need to be employed at this point to give due regard to the complexity of the lives involved.

Spectrum Pharmaceuticals has signed an agreement to acquire licensing rights to market ZEVALIN (ibritumomab tiuxetan) injection for intravenous use outside of the US from Bayer Healthcare.

As per the agreement, Spectrum will have all rights related to marketing, sales, and patents, and access to existing inventory of ZEVALIN from Bayer.

The Merchant Banking Group of Burrill & Company acted as advisor to Spectrum Pharmaceuticals in this transaction.

Spectrum will utilize a combination of company resources and partnerships to support the product outside the US, the company said.

ZEVALIN is approved for the treatment of follicular B-cell non-Hodgkin’s lymphoma, including countries in Europe, Latin America and Asia.

Spectrum chairman and CEO Rajesh Shrotriya said that with the licensing of ex-US, worldwide rights to ZEVALIN, they will be able to leverage their existing clinical, regulatory and marketing investments.

“Our access to the worldwide market will help patients with follicular lymphoma who can benefit from ZEVALIN,” Shrotriya added.

Auxilium Pharmaceuticals, Inc. Announces First Patients Dosed in XIAFLEX® Phase Ib Cellulite Study

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that the first cohort of patients has been dosed in its phase Ib trial of XIAFLEX® (collagenase clostridium histolyticum) for the treatment of edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite. Cellulite has been reported to occur in 85-98% of post-pubertal females and rarely in men. The condition is prevalent in women of all races. (1,3)

Cellulite is described as a localized metabolic disorder of tissue under the skin, which can involve the loss of elasticity or shrinking of collagen cords, called septae, that attach the skin to lower layers of muscle. When fat in cellulite prone areas swells and expands, the septae tether the skin, which causes surface dimpling characteristic of cellulite. XIAFLEX treatment is intended to target and lyse, or break, those collagen tethers with the goal of releasing the skin dimpling and potentially resulting in smoothing of the skin.

“For many women, cellulite can be a source of considerable embarrassment or self-consciousness,” said Dr. James Tursi, Chief Medical Officer at Auxilium. “Current treatments of cellulite with creams, light-based procedures or liposuction provide limited or no effectiveness. The clinical development of XIAFLEX, if successful, could lead to the first FDA-approved, office-based medical treatment option that is supported by scientific results.”

The phase Ib study is a single site, open-label dose-escalation study that is targeted to enroll 63 women between 21 and 60 years of age. The objectives of the study are to assess the safety, effectiveness, and pharmacokinetics of XIAFLEX for the treatment of EFP. Topline results are expected in the second half of 2012.

“Dosing in the cellulite clinical trial represents another important development milestone for Auxilium as we advance a fourth potential indication of XIAFLEX into the clinic, further diversifying XIAFLEX’s growing pipeline,” explained Adrian Adams, Chief Executive Officer and President of Auxilium. “We believe cellulite represents a significantly undertreated condition and that innovative approaches such as XIAFLEX may one day be a viable solution for treatment.”

To qualify for the study, participants must have EFP in the posterolateral thighs and/or buttocks for at least 12 months prior to a screening visit. Following screening and determination of eligibility, study participants will be assigned to one of seven groups that vary in treatment dose, injection concentration and volume. Subjects will receive 10 concurrent injections (0.1 or 0.5 mL per injection) of XIAFLEX via a standardized template over a targeted area (8 cm x 10 cm) of EFP. The total dose of XIAFLEX that will be administered into the targeted area will range between 0.0029 mg and 0.116 mg; these doses represent between 0.5% and 20% of the dose used in a single injection for Dupuytren’s contracture (0.58 mg). Safety will be evaluated through the collection of adverse events, as well as a targeted assessment of local reactions to the treatment. The treatment effectiveness will be evaluated by investigator and patient assessments, as well as 3-D photographic imaging techniques.

About CelluliteCellulite, also known medically as edematous fibrosclerotic panniculopathy, describes a pathologic inflammatory condition, in which lobules of subcutaneous adipose tissue extend into the dermal layer. These changes can visibly affect the shape of the epidermis and resemble an orange peel-like dimpling of the skin.(1)

In the normal subcutaneous fat layer directly under the skin, there are both perpendicular columnar and net-like fibrous connective tissue called septae. These fibrous septae, made of types I and III collagen, connect the epidermis to the dermis and create a network of compartmentalized adipose deposits. Women tend to have a higher proportion of columnar septae that are perpendicular to the epidermis, while men tend to have more of the net-like system. In cellulite, the subcutaneous fat cells swell and push upwards. (2) As a result, the skin between the septae is pushed up and the perpendicular septae act as an anchor to pull the epidermis downwards and form the classic cellulite dimple. The surrounding adipose tissue forms small bulges under the epidermis around the dimple that can give skin a “cottage cheese” texture.

Cellulite occurs mainly on the pelvic region, lower limbs, and abdomen and has been reported to occur in 85-98% of post-pubertal females and rarely in men. The condition is prevalent in women of all races. (1,3) Cellulite is different from generalized obesity. The fat cells found in generalized obesity are not limited to the pelvis, thighs, and abdomen. Further, the fat cells found in cellulite have different physiologic and biochemical property than fat tissue located elsewhere.(3) There is no definitive medical explanation for the presentation and prevalence of cellulite and, despite multiple types of therapeutic approaches for the attempted treatment of cellulite, there are no approved treatments and little scientific evidence that any current treatments are beneficial.(4)

About XIAFLEXXIAFLEX (collagenase clostridium histolyticum) is a biologic approved in the U.S. and the EU for the treatment of adult Dupuytren’s contracture patients with a palpable cord. XIAFLEX is a minimally invasive treatment for this condition and consists of a highly purified combination of several subtypes of collagenase, derived from clostridium histolyticum, in specific proportion. Together, the collagenase sub-types work synergistically to break the bonds of the triple helix collagen structure more effectively than human collagenase. XIAFLEX is currently in phase III of a global development program for the treatment of Peyronie’s disease, in phase IIa of development for the treatment of Frozen Shoulder syndrome (adhesive capsulitis) and in phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy).

About AuxiliumAuxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopedic, general, and plastic surgeons who focus on the hand, and rheumatologists. Auxilium markets XIAFLEX® (collagenase clostridium histolyticum) for the treatment of adult Dupuytren’s contracture patients with a palpable cord and Testim® 1%, a testosterone gel, for the topical treatment of hypogonadism in the U.S. Pfizer has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in Europe and Asahi Kasei Pharma Corporation has development and commercial rights for XIAFLEX in Japan. Ferring International Center S.A. markets Testim in the EU and Paladin Labs Inc. markets Testim in Canada. Auxilium has three projects in clinical development. XIAFLEX is in phase III of development for the treatment of Peyronie’s disease, in phase IIa of development for the treatment of Frozen Shoulder syndrome (Adhesive Capsulitis) and in phase Ib of development for the treatment of cellulite (edematous fibrosclerotic panniculopathy). Auxilium also has rights to pursue additional indications for XIAFLEX. For additional information, visit http://www.auxilium.com.

SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995This release contains “forward-looking-statements” within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding the potential for XIAFLEX to treat edematous fibrosclerotic panniculopathy, commonly known as cellulite; the timing of release of topline results from the phase Ib study of XIAFLEX for the treatment of cellulite; the number of people with cellulite and the market opportunity represented by that number ; and products in development for Peyronie’s disease, Frozen Shoulder syndrome and cellulite; and all other statements containing projections, statements of future performance or expectations, our beliefs or statements of plans or objectives for future operations (including statements of assumption underlying or relating to any of the foregoing). Forward-looking statements can generally be identified by words such as “believe,” “appears,” “may,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and other words and terms of similar meaning in connection with any discussion of projections, future performance or expectations, beliefs, plans or objectives for future operations (including statements of assumption underlying or relating to any of the foregoing). Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including further evaluation of clinical data, results of clinical trials, decisions by regulatory authorities as to whether and when to approve drug applications, and general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in Auxilium’s Annual Report under the heading “Risk Factors” on Form 10-K for the year ended December 31, 2010 and the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2011, which are on file with the Securities and Exchange Commission (the “SEC”) and may be accessed electronically by means of the SEC’s home page on the Internet at http://www.sec.gov or by means of Auxilium’s home page on the Internet at http://www.Auxilium.com under the heading “For Investors — SEC Filings.” There may be additional risks that Auxilium does not presently know or that Auxilium currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.

In addition, forward-looking statements provide Auxilium’s expectations, plans or forecasts of future events and views as of the date of this release. Auxilium anticipates that subsequent events and developments will cause Auxilium’s assessments to change. However, while Auxilium may elect to update these forward-looking statements at some point in the future, Auxilium specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Auxilium’s assessments as of any date subsequent to the date of this release.

Watson Pharmaceuticals Incorporated (NYSE: WPI) was downgraded by investment analysts at Citigroup (NYSE: C) from a “buy” rating to a “neutral” rating in a note issued to investors on Tuesday.

Separately, analysts at Goldman Sachs (NYSE: GS) reiterated a “conviction buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Monday. Analysts at Credit Suisse (NYSE: CS) cut their EPS estimates on shares of Watson Pharmaceuticals Incorporated in a research note on Monday. They now have an “outperform” rating and a $77.00 price target on the stock. Also, analysts at Needham & Company reiterated a “hold” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Monday.

Watson Pharmaceuticals, Inc. (Watson) is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution. It operates in international markets, including Western Europe, Canada, Australasia, Asia, South America and South Africa with its commercial market being the United States of America. As of December 31, 2010, it marketed approximately 160 generic pharmaceutical product families and approximately 30 brand pharmaceutical product families in the United States, and distributed approximately 8,500 stock-keeping units (SKUs) through its Distribution Division. In January 2010, the Company acquired 64% of Eden Biopharm Group Limited (Eden). In May 2011, it acquired Specifar Pharmaceuticals S.A.

Shares of Watson Pharmaceuticals Incorporated traded down 2.88% during mid-day trading on Tuesday, hitting $55.56. Watson Pharmaceuticals Incorporated has a 52 week low of $53.46 and a 52 week high of $73.35. The stock’s 50-day moving average is $61.05 and its 200-day moving average is $65.34. The company has a market cap of $7.065 billion and a P/E ratio of 39.35.

Formula Pharmaceuticals Appoints Martyn Greenacre to Board of Directors

Formula Pharmaceuticals, a privately-held oncology drug development company, today announced the appointment of Martyn Greenacre to the Board of Directors. Mr. Greenacre served as Chairman of BMP Sunstone Corporation, a pharmaceutical company recently acquired by Sanofi-Aventis.

“Martyn is a highly-valued addition to our Board of Directors,” said Maurits W. Geerlings, Chief Executive Officer of Formula Pharmaceuticals. “His proven leadership, coupled with his extensive business and corporate development experience in the pharmaceutical industry, will be invaluable to us as we advance our lead clinical-stage program.”

Previously, Mr. Greenacre served as Chief Executive Officer and Director of Delsys Pharmaceutical Corporation, a formulation and drug delivery system company, where he helped raise more than $50 million in equity and partnership financing and formed three development partnerships with leading pharmaceutical companies. Prior to that, Mr. Greenacre served as President and Chief Executive Officer of Zynaxis Inc., a biopharmaceutical company, where he was responsible for a critical acquisition, divesting a non-performing business and negotiating a strategic merger. Mr. Greenacre also held positions of increasing responsibility in the European division of SmithKline Beecham Pharmaceutical Company, rounding out his time there as Chairman, Europe.

“I am excited to join the Formula leadership team at a time when the company is moving its lead drug candidate, FPI-01, towards Phase 2 clinical development for the treatment of first-remission acute myeloid leukemia and other cancers,” said Mr. Greenacre. “I look forward to contributing my knowledge and expertise to supporting major milestones that are on the horizon for the company.”

Mr. Greenacre has also served on a number of start-up company Boards and currently serves as Chairman of the Board of Acusphere, Inc. (a drug delivery company), as Chairman of Life Mist Technologies, Inc. (a hospital biological decontamination company), and sits on the board of Curis, Inc. (a biotechnology company). Mr. Greenacre received a B.A. from Harvard College and an MBA from Harvard Business School.

About Formula Pharmaceuticals

Formula Pharmaceuticals, Inc. is a privately-held, oncology drug development company advancing novel medicines to address areas of unmet therapeutic need in cancer. Formula’s lead product candidate, FPI-01, is a first-in-class immunotherapeutic in clinical development for the maintenance of first-remission in acute myeloid leukemia (AML) and other cancers. Building upon deep industry expertise in identifying, licensing and developing novel medical approaches, Formula’s focus is on accelerating future life-saving cancer therapies.

Founded in late 2009 by Dr. Geerlings and Dr. Mosconi, Formula has assembled a world-class scientific, clinical development and business team well positioned to maximize the clinical and commercial value of promising drug candidates through excellence in drug development and strategic partnering.

Santhera and Ipsen Renegotiate Fipamezole Licensing Agreement

Santhera Pharmaceuticals (SIX: SANN) and Ipsen (Euronext: IPN, ADR: IPSEY) announced today that they have renegotiated their fipamezole licensing agreement. Santhera regains the worldwide rights to the development and commercialization of fipamezole, its first-in-class selective adrenergic alpha-2 receptor antagonist for the management of levodopa-induced Dyskinesia in Parkinson’s Disease. Under the renegotiated terms, Ipsen returns its rights for territories outside of North America and Japan in exchange for milestone payments and royalties based on future partnering and commercial success of fipamezole. Ipsen retains a call option for worldwide license to the program under certain conditions.

Thomas Meier, Chief Executive Officer of Santhera, commented: “Under the agreement reached with Ipsen, Santhera has regained global marketing rights for fipamezole, which we can further develop in line with the Company’s strategy. In the short term, the focus of our investments remains on our lead product Catena(R) and its multiple product opportunities in neuromuscular and mitochondrial orphan indications. However, fipamezole continues to be a valuable asset in Santhera’s late-stage clinical pipeline.”

Pierre Boulud, Ipsen’s Executive Vice-President, Corporate Strategy stated: “We are pleased that Santhera regains the worldwide rights to an agent like fipamezole. This new agreement will help to leverage the drug’s value on a global basis while allowing Ipsen to focus on its rich late stage development pipeline. With its important commercial overlap with movement disorders, Parkinson Disease remains an important area of commercial focus for Ipsen. Santhera’s commitment to this first-in-class drug has the potential to benefit levodopa-induced dyskinesia in Parkinson’s Disease patients in crucial need of better therapies.”

About the agreement
According to a licensing agreement signed in September 2010, Ipsen had acquired the rights to fipamezole outside the United States, Canada and Japan for an upfront payment of 13 million euros. Under the new agreement, Santhera regains full control over the development and commercialization of fipamezole, whilst Ipsen is entitled to receive milestone and royalty payments contingent upon the occurrence of certain events. Santhera is free to license the program to a third party whereby Ipsen is entitled to receive a percentage of any license income. In addition, the agreement includes a call option allowing Ipsen under certain circumstances to obtain an exclusive worldwide license. Should Ipsen exercise this call option, Santhera will receive milestone and royalty payments from Ipsen.

About Fipamezole
Fipamezole is widely perceived by clinicians as one of the most promising drug candidates to treat Dyskinesia in Parkinson’s Disease, the second most common and a severely debilitating neurodegenerative disorder. As a highly selective adrenergic alpha-2 receptor antagonist, fipamezole is an innovative, first-in-class drug in clinical development for the treatment of levodopa-induced Dyskinesia in Parkinson’s Disease. Santhera successfully completed two Phase II clinical studies which demonstrated efficacy and safety of fipamezole in the treatment of dyskinesia in Parkinson’s Disease. Fipamezole also showed attractive potential for the reduction of levodopa “wearing-off”, and demonstrated improvement in cognition and activities of daily living.

About Santhera
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative pharmaceutical products for the treatment of orphan neuromuscular and mitochondrial diseases, areas of high unmet medical with no current therapies. Santhera’s first product Catena(R) is currently marketed in Canada to treat Friedreich’s Ataxia. Catena(R) is also under review for marketing authorization by the European Medicine Agency as the first therapy for patients suffering from Leber’s Hereditary Optic Neuropathy.

Cubist Pharmaceuticals (CBST) posted its quarterly earnings results on Thursday. The company reported $0.11 earnings per share (EPS) for the quarter, missing the Thomson Reuters consensus estimate of $0.31 by $0.20. The company’s quarterly revenue was up 31.6% on a year-over-year basis.

On a related note, analysts at Bank of America (NYSE: BAC) reiterated a “buy” rating on shares of Cubist Pharmaceuticals in a research note to investors on Wednesday, January 11st. Also, analysts at Jefferies Group (NYSE: JEF) reiterated a “buy” rating on shares of Cubist Pharmaceuticals in a research note to investors on Tuesday, January 10th. They now have a $48.00 price target on the stock.

Cubist Pharmaceuticals (CBST) traded down 1.51% on Thursday, hitting $40.40. Cubist Pharmaceuticals (CBST) has a 52-week low of $20.95 and a 52-week high of $42.10. The stock has a 50-day moving average of $39.19 and a 200-day moving average of $36.15. The company has a market cap of $2.487 billion and a price-to-earnings ratio of 71.22.

Cubist Pharmaceuticals, Inc. (Cubist) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. The Company’s products are used primarily in hospitals, but also may be used in acute care settings, including home infusion and hospital outpatient clinics. Cubist’s owns CUBICIN (daptomycin for injection), which is a once-daily, bactericidal, intravenous (I.V.) antibiotic with activity against certain Gram-positive organisms, including methicillin-resistant Staphylococcus aureus (S. aureus), (MRSA). During the year ended December 31, 2009, this product was used in the treatment of more than an estimated 880,000 patients. In December 2009, the Company acquired Calixa Therapeutics Inc.

Paula Deen says she has diabetes, will endorse pharmaceutical company

Paula Deen made waves this week when she announced that she’d be diagnosed with Type 2 diabetes.

Deen isn’t just any other American, though. She hosts a cooking show, renowned for its liberal use of fats, sugars and especially butter. And instead of announcing the diabetes to say she was going to change her ways, Deen went in a different direction.

She announced she was becoming a paid spokeswoman for pharmaceutical giant Novo Nordisk AS, which makes diabetes drugs such as Victoza. Deen said she was diagnosed three years ago but kept the matter private — seemingly until she could find a way to turn the diagnosis into a financial windfall.

Deen’s behavior has outraged some, particularly those who think lifestyle changes are important for dealing with, and potentially reversing, the effects of Type 2 diabetes.

Suzanne Vranica, a reporter for The Wall Street Journal who’s examined Deen’s announcement, said consumers think this Deen’s behavior is a complete sham.

“I think the real reason we’re seeing this problem is because she’s known for so long she’s had these problems and she’s done nothing in terms of her show and her books to promote a healthy lifestyle, which is needed when you’re combatting this sort of diabetes,” she sid.

Celebrity Chef Anthony Bourdain didn’t hold back in his criticisms either.

“Thinking of getting into the leg-breaking business, so I can profitably sell crutches later,” he tweeted.

Vranica described Deen’s problem as talking out of both sides of her mouth.

“The real crux of the problem is she’s basically tip-toed around this question about, “Well, on your show, will you now begin to promote healthier lifestyles.’ Although her spokespeople have said she’s in discussions to do that, it’s been slow going,” Vranica said.

They also point out that her son’s new show will feature healthier food.

But no matter how it turns out, Vranica said, there will be real ramifications for Deen and her brand because of this.

“Her brand was soaring up until now. What will happen to her book sales? Will people tune out,” Vranica said. “Given the reaction we’ve seen on social media sites, I anticipate there’s definitely going to be some financial fallout for her.”

China Health Resource Pharmaceutical Grade Gastrodia Product Line Expected to Contribute $8 Million in Revenue to 2011 Year End

China Health Resource, Inc. CHRI
+68.18% , announced
today that its pharmaceutical grade Gastrodia based product line has experienced double digit sales growth in 2011 with increased profit margins. The Gastrodia product line is expected to generate an estimated 50 million yuan (US$8 million) of revenue in 2011 for CHRI. The strength of the Company’s core product lines and rapid growth in newer higher margin products is expected to drive record revenue and earnings. The Company will confirm the disclosed preliminary figures at the time of disclosure of the annual report for 2011.

China Health Resource, Inc. entered into an exclusive agreement with a leading producer of Gastrodia in Pingwu, Sichuan in April 2011. The agreement gives CHRI leverage in the Traditional Chinese Medicine (TCM) marketplace in China, as the main controlling distributor and supplier of Gastrodia (also known as Tianma). Gastrodia currently retails for about 250~1,000 yuan/kg (US$38~150/kg) and is considered one of China’s highest value TCM drugs available in the market. This exclusive arrangement for the supply of Gastrodia is expected to generate an estimated combined total of 50 million yuan (US$8 million) of revenue for CHRI over the 2011-2012 period.

“Our core strength in establishing DAR as a standard has resulted in an enviable growth in revenues and margins in our DAR product line and the Gastrodia product line is the natural progression of CHRI product on large global markets with higher profit margins. We expect this will be reflected in our 2011 year in both revenues and earnings” stated Jiayin Wang, Chairman and CEO of CHRI.

“Gastrodia is an important herb with high margins and we expect it will add a significant contribution to our top and bottom line. As a TCM ingredient, it has pain relieving and anti-inflammatory properties, and it is used in the treatment of severe headaches and nervous fatigue. In time, we expect Gastrodia to have the same standard of acceptance as GAP DAR.” added Jiayin Wang.

Slowing growth continues in major developed markets, prompted by generic erosion of branded sales and increasing regulatory and cost containment pressures. Expansion into emerging Asia Pacific (APAC) markets is appealing not only because of their rapid growth and sizeable patient populations, but also because operating environments are improving as these countries open up to global trade.

Features and benefits

* Overview of drivers, resistors and trends within the Asia Pacific M&A landscape.* Summary of geographic M&A activity on a regional and country-specific basis.* Analysis of the types of acquisitions and healthcare sectors targeted.* Examination of transaction values and leading dealmakers.

Highlights

India, Japan and Australia all continued to record frequent deal activity, although China increased its lead in terms of total deal numbers in 2010 and early 2011. However, Chinese companies continue to focus primarily on domestic transactions.Japanese companies still account for the majority of M&A deal value. The first half of 2011 has already surpassed previous peak M&A deal values in APAC, continuing the annual upward trend seen in transaction values when outlying multi-billion dollar deals are excluded.While most M&As involving APAC-based players target pharmaceutical and biological products companies, such as generics and active pharmaceutical ingredient (API) manufacturers, medical devices and equipment firms have recently taken over as the leading sector targeted for M&A.

Research and Markets: France Pharmaceuticals and Healthcare Report Q1 2012

Despite the government’s focus on fiscal consolidation – which includes various cost containment measures impacting the country’s healthcare and pharmaceutical spending – France will remain one of the most attractive pharmaceutical markets on a global scale. High usage of (especially patented) medicines on a per capita basis will continue to provide considerable commercial opportunities for multinational drug makers. While generic drugs will continue to increase their share of the total market’s value in the medium term, patented medicines are still expected to represent at least two-thirds the market by 2015, at a consumer price value of a significant EUR18.1bn (US$22.6bn).

Following cost-containment measures rolled out in 2010 and 2011, the authorities are poised to introduce further austerities in 2012. Proposed measures include savings of EUR910mn (US$1.23bn) achieved via price cuts on (mostly) generic medicines, and savings of EUR40mn (US$54mn) in reimbursement listings. The proposal sets the target annual growth in public expenditure on healthcare at 2.5% (from the previously proposed 2.8%) for each year from 2012 to 2015, which could see the pharmaceuticals industry more than EUR1bn worse off.

In October 2011, French pharmaceutical companies Servier and Hybrigenics signed a three year deal in the field of deubiquitinating enzymes to research first-in-class medicines to treat several diseases, particularly cancer. Under the licence and research collaboration agreement, Hybrigenics will get EUR4mn (US$5.5mn) from an up front fee and research funding, along with royalties on sales of diagnostic kits and EUR9.5mn (US$13.07mn) for each target successfully leading to registration.

Leading domestic drug producer Sanofi is expecting average annual growth of 5% from 2012- 2015, according to recent reports. The company aims to shift into new areas, including vaccines and animal health as sales of drugs like blood thinner Plavix (clopidogrel) and cancer drug Taxotere (docetaxel) are declining following the loss of patent protection. The company is also looking for extra cost savings of EUR2bn (US$2.8bn), as well as improving research and development capabilities to encourage sustainable growth.

Publication Overview:

Business Monitor International’s France Pharmaceuticals and Healthcare Report provides industry professionals and strategists, corporate analysts, pharmaceutical associations, government departments and regulatory bodies with independent forecasts and competitive intelligence on France’s pharmaceuticals and healthcare industry.

Astex Announces Early Transfer of Epigenetics Project to GSK

Astex Pharmaceuticals, Inc. ASTX
-0.02% today announced that the multi-year collaboration to
discover cancer therapeutics based on epigenetic targets entered into by SuperGen, Inc. and GlaxoSmithKline (GSK) in November 2009 is terminating and existing research work and assets generated under the CLIMB(TM) epigenetic collaboration will be transferred to GSK. Astex will have no further obligation to conduct additional research work on the program. This decision follows on from the review and rationalization of Astex’s internal pipeline and drug discovery programs as part of the recent merger of Astex Therapeutics Limited and SuperGen, Inc. to form Astex Pharmaceuticals, Inc., and discussions with GSK. As a result of the transfer, Astex will continue to be eligible to receive milestones and royalties under an asset transfer agreement. A separate Research and Development Collaboration and License Agreement which includes a multi-target drug discovery collaboration, entered into by Astex’s UK subsidiary, Astex Therapeutics Limited and GSK in November 2009 will continue as previously announced.

“The decision to transfer the CLIMB(TM) epigenetic program to GSK was based on our assessment of internal resources and discussions with GSK,” said Harren Jhoti, PhD, president of Astex Pharmaceuticals. “We continue to work closely with GSK on the discovery of molecules using our Pyramid(TM) fragment platform as part of our successful and ongoing collaboration against multiple targets of interest to GSK entered into in November 2009.”

About Astex Pharmaceuticals

Astex Pharmaceuticals is dedicated to the discovery and development of novel therapeutics with a focus on oncology. The Company is developing a proprietary pipeline of novel therapies and is creating de-risked products for partnership with leading pharmaceutical companies. Astex Pharmaceuticals developed Dacogen(R) (decitabine) for Injection and receives significant royalties on global sales.

Drug maker Novartis will cut 1,960 jobs in the United States this year in anticipation of lower sales for two of its hypertension drugs, the Swiss company said Friday.

Basel-based pharmaceutical giant Novartis AG said the cuts will affect 1,630 sales positions in the field and 330 posts at its U.S. headquarters in New Jersey.

The restructuring was necessary because of the expiration of its patent for the best-selling hypertension drug Diovan and the failure of a clinical study into another hypertension drug, Tekturna, Novartis said.

“We recognize that the next two years will be challenging in the Pharmaceuticals Division and we are proactively making these changes to further focus our pipeline on the best opportunities and align our market position on our growth brands,” the head of Novartis’ pharmaceuticals division, David Epstein, said in a statement. “These are difficult but necessary decisions that will free up resources to invest in the future of our business which we view as well suited to bring new valuable therapies to patients and payors.”

In 2010 the company eliminated 1,400 U.S. sales jobs, followed by 900 U.S. development posts last October.

Novartis said the latest job cuts would save $450 million a year from 2013 after an initial charge of $160 million, to be booked in the first quarter of 2012.

Diovan contributed $1.43 billion to Novartis’ net pharmaceutical sales of $8.16 billion in the third quarter. Its patent expiry is likely to markedly increase competition from generic products.

Meanwhile, Novartis said a reassessment of the future sales potential of Tekturna, which is known as Rasilez outside of the U.S., will result in an exceptional charge of $900 million in the fourth quarter. The company said last month it had terminated a trial into the expanded use of Tekturna after it was found to cause increase complications in patients already taking other common hypertension drugs.

Two other experimental drugs will also be dropped, leading to one-off charges of $160 million in the fourth quarter, Novartis said.

In its statement, Novartis made no mention of a recent announcement that it was recalling several over-the-counter drugs in the United States following reports of a possible mix-up with powerful prescription pain medications at a Nebraska manufacturing plant.

Novartis shares closed 0.7 percent lower at 53.00 Swiss francs ($55.59) on the Zurich exchange Friday.

Savient Pharma Names David Veitch President Of Savient Europe – Quick Facts

Savient Pharmaceuticals, Inc. (SVNT) said it named David Veitch President of Savient Europe, effective January 16, 2012. Veitch will report directly to John Johnson, Chief Executive Officer and President of Savient. He will be responsible for establishing, building and leading Savient’s European regional organization to launch and drive the future growth of KRYSTEXXA.

Veitch has over 24 years of pharmaceutical industry experience.

Watson Pharmaceuticals Incorporated (WPI) EPS Estimates Cut by Goldman Sachs (GS)

Investment analysts at Goldman Sachs (NYSE: GS) lowered their EPS estimates on shares of Watson Pharmaceuticals Incorporated (NYSE: WPI) in a note issued to investors on Friday. They currently have a “buy” rating and a $78.00 price target on the company’s shares.

Separately, analysts at Jefferies Group (NYSE: JEF) reiterated a “hold” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday, December 20th. They now have a $70.00 price target on the stock. Analysts at Citigroup (NYSE: C) reiterated a “buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday, December 20th. They now have a $82.00 price target on the stock. Also, analysts at Canaccord Genuity reiterated a “buy” rating on shares of Watson Pharmaceuticals Incorporated in a research note to investors on Tuesday, December 20th.

Watson Pharmaceuticals, Inc. (Watson) is an integrated global pharmaceutical company engaged in the development, manufacturing, marketing, sale and distribution of generic and brand pharmaceutical products. It operates in three segments: Global Generics, Global Brands and Distribution. It operates in international markets, including Western Europe, Canada, Australasia, Asia, South America and South Africa with its commercial market being the United States of America. As of December 31, 2010, it marketed approximately 160 generic pharmaceutical product families and approximately 30 brand pharmaceutical product families in the United States, and distributed approximately 8,500 stock-keeping units (SKUs) through its Distribution Division. In January 2010, the Company acquired 64% of Eden Biopharm Group Limited (Eden). In May 2011, it acquired Specifar Pharmaceuticals S.A.

Shares of Watson Pharmaceuticals Incorporated traded up 0.23% during mid-day trading on Friday, hitting $62.19. Watson Pharmaceuticals Incorporated has a 52 week low of $51.39 and a 52 week high of $73.35. The stock’s 50-day moving average is $62.05 and its 200-day moving average is $65.82. The company has a market cap of $7.908 billion and a price-to-earnings ratio of 42.68.