Pharmaceutical News: Pulmatrix iSPERSE drug delivery system yields positive data

Pulmatrix iSPERSE drug delivery system yields positive data

Pulmatrix’s iSPERSE inhaled drug platform showed multi-drug delivery abilities and superiority over conventional lactose blending for an effective therapeutic dose of the active ingredients in Advair, salmeterol and fluticasone, as well as an additional anticholinergic bronchodilator.

iSPERSE is a novel inhaled dry powder delivery platform developed by Pulmatrix for use in the delivery of drugs via inhalation for local or systemic applications.

The preclinical data of iSPERSE suggested that it can efficiently deliver consistent double- and triple-combination drug doses and offers improved drug efficacy and safety for patients having both normal and lower or impaired lung function.

In the in vitro and preclinical studies, an iSPERSE fluticasone and salmeterol combination was matched to commercially available Advair Diskus, which contains the fluticasone and salmeterol combination blended with lactose to enable pulmonary delivery.

iSPERSE demonstrated improved delivery efficiency over Advair Diskus, as iSPERSE was shown to deliver over 2 times more lung dose of the active pharmaceutical ingredients than Advair Diskus.

In addition, iSPERSE behaved flow rate independently at flow rates of 28.3 and 60.0 LPM, maintaining a similar fine particle fraction when tested via actuation from a capsule-based passive dry powder inhaler.

Collins Stewart Analysts Reiterate a “Buy” Rating on Impax Laboratories (IPXL)

Impax Laboratories (NASDAQ: IPXL)‘s stock had its “buy” rating reaffirmed by equities research analysts at Collins Stewart in a research note issued to investors on Tuesday.

Separately, analysts at Canaccord Genuity reiterated a “hold” rating on shares of Impax Laboratories in a research note to investors on Tuesday. Analysts at Piper Jaffray (NYSE: PJC) reiterated an “overweight” rating on shares of Impax Laboratories in a research note to investors on Thursday, December 1st. They now have a $32.00 price target on the stock.

Impax Laboratories, Inc. is a technology-based, specialty pharmaceutical company. The Company is focused on the development and commercialization of bioequivalent and brand-name pharmaceuticals. In the generic pharmaceuticals market, the Company focuses on controlled-release generic versions of brand-name pharmaceuticals, covering a range of therapeutic areas. In the brand-name pharmaceuticals market, the Company is developing products for the treatment of central nervous system (CNS) disorders.

Raptor Pharmaceutical Corp. Provides Program Update on RP103 (DR Cysteamine) for Nephropathic Cystinosis

Raptor Pharmaceutical Corp. (“Raptor” or the “Company”) RPTP
-1.91% announced today a program
update for its lead investigational compound, RP103 for the potential treatment of nephropathic cystinosis. RP103 is Raptor’s proprietary, enteric-coated, microbead delayed-release oral formulation of cysteamine bitartrate designed to potentially reduce dosing frequency and reduce gastrointestinal side effects associated with the currently approved immediate-release cysteamine bitartrate.

Following the successful completion of Raptor’s pivotal Phase 3 clinical trial of RP103, which was announced in July 2011, the Company has been conducting a planned voluntary extension study to monitor white blood cell (“WBC”) cystine levels and collect long-term safety and quality of life data. Of the 40 patients who entered the safety study after completing the Phase 3 clinical trial, 38 are currently still enrolled. All of these 38 patients have now been taking RP103 in the extension study for at least 6 months, with some patients having been in the extension study for as long as 15 months. Raptor intends to include at least 6 months of safety data for all Phase 3 completers who remain in the extension study, with its New Drug Application (“NDA”) and Marketing Authorization Application (“MAA”) filings that are expected to be filed in the first calendar quarter of 2012. The Company plans to keep the extension study open to all enrolled patients until RP103 becomes locally commercially available.

Based on the positive results of Raptor’s Phase 3 clinical trial and on the findings of its bioequivalence study, which demonstrated similar drug exposure whether administered in whole capsule or sprinkled onto applesauce, US and European regulatory agencies approved the Company’s expanded enrollment in the extension study to include patients who did not qualify for the Phase 3 clinical trial. These patients include children 1-6 years old and patients who have undergone a kidney transplant. Ten of an anticipated 18 additional patients have already enrolled in the expanded extension study. The Company also plans to study RP103 in cystinosis patients who have either stopped taking or have not been adequately controlled with the currently-marketed, immediate-release cysteamine bitartrate. While the data for these additional patient groups are not required to be included in Raptor’s NDA and MAA filings, the Company expects to include them in subsequent updates to these marketing applications.

“The data from these additional study patients will be helpful for physicians in determining optimal treatments in a broader population of patients with nephropathic cystinosis than we were able to study in our Phase 3 clinical trial,” said Patrice P. Rioux, M.D. Ph.D., Raptor’s Chief Medical Officer.

Raptor has completed pre-submission meetings with the US Food and Drug Administration (“FDA”) and the European Medicines Agency (“EMA”) and is on track to submit marketing applications in both markets in the first calendar quarter of 2012. Raptor plans to file for “Priority Review” in the US and “Accelerated Approval” in the EU. If granted, the Company could potentially receive approval for the sale of RP103 for the treatment of nephropathic cystinosis in both the US and the EU in the fourth calendar quarter of 2012. In anticipation of the potential approval in 2012, Raptor is actively building its US and European commercial infrastructure and pre-commercial programs to market RP103.

About Nephropathic Cystinosis

Nephropathic cystinosis is a rare disease resulting from an inborn metabolic error characterized by the abnormal transport of cystine, an amino acid, out of lysosomes. Poor compliance with current treatments for nephropathic cystinosis can cause serious health consequences, including: renal failure and resultant need for a kidney transplant; growth failure; rickets and fractures; and photophobia and blindness. Symptom onset typically occurs within the first year of life, when cystine crystals accumulate in various tissues and organs, including the kidneys, brain, liver, thyroid, pancreas, muscles and eyes.

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