Pharmaceutical News: FDA approves Taro’s Canadian pharmaceutical facility

FDA approves Taro’s Canadian pharmaceutical facility

Taro Pharmaceutical Industries Ltd. (Pink Sheets: TAROF) can resume regular production at its Canadian manufacturing facility, after the US Food and Drug Administration (FDA) approved the facility, following a re inspection of the site in February 2011. The facility is located in the Toronto suburb of Brampton.

Taro said that the issues raised in the FDA warning letter of February 5, 2009 are considered to be resolved.

The FDA has been tightening its enforcement in recent years, sending warning letters to many pharmaceutical companies about faults found in their manufacturing facilities. The inspection at the Brampton facility related to flaws in the production of an anti-itch and acne cream Fluocinonide and for ringworm cream Cicloopirox Olamine.

Taro interim CEO James Kedrowski said, “We have worked diligently at the Brampton facility to resolve the issues noted in the last inspection and are pleased that our efforts have brought the facility back into good standing with the Agency. We are dedicated to developing and manufacturing quality products for our customers while meeting and exceeding all Good Manufacturing Practices (GMP) standards set by the FDA and Health Canada.”
Taro’s share price closed at $14.40 yesterday, giving a market cap of $566 million.

Cumbria shortlisted for new pharmaceutical factory

Cumbria is on the shortlist for a new pharmaceutical factory that would produce groundbreaking drugs to treat illnesses.

GlaxoSmithKline (GSK) has included Ulverston on a list of potential locations for a new ‘biopharmaceutical’ plant.

Other sites including Irvine and Montrose, in Scotland, and Barnard Castle, County Durham, are also under consideration.

Glaxo is expected to make a decision by the end of the year, with construction and commissioning expected to take about five years to complete.

If Ulverston is chosen it would be a massive boost for the site which has suffered several waves of redundancies in recent years.

The firm is currently downsizing from 540 people to between 210 and 240 there as part of a plan set out in 2008.

That plan includes “outsourcing of some lower complexity intermediate manufacturing, re-engineering the site layout to remove old facilities and equipment, and the reduction of site headcount”.

Bosses announced a further 20 compulsory redundancies in February.

The restructure will see the Ulverston site continue to focus on “very specialist sterile manufacture and oral spraying technologies”, Glaxo said.

Bosses say the site has continued to perform “extremely well” throughout the transition.

Protect Pharmaceutical Corporation Appoints Chief Executive Officer and Chief Financial Officer

Protect Pharmaceutical Corporation (OTCBB: PRTT) today announced its Board of Directors has appointed current Chief Operating Officer Ramesha Sesha as its Chief Executive Officer and Chairman of the Board, effective immediately. Mr. Sesha joined Protect as the Chief Operating Officer and Board Member in March 2011, following the Patent Acquisition Agreement with Nectid Inc where he was the Founder and CEO.

Mr. Sesha has over 15 years experience in both the brand and generic pharmaceutical industry. He is an Organic chemist and was the Senior Vice President for Intellectual Property and US FDA Submissions, with Wockhardt Limited in Bedminster, New Jersey. His role included managing the IP portfolio, R & D strategy and was a part of the M & A team. He founded Nectid Inc, a privately held R & D firm and has licensed or sold 19 patents to different pharmaceutical companies in the last 24 months.

Mr. Sesha’s promotion reflects Protect’s strategy to ensure its scientific and corporate visions are aligned together.

The Board of Directors also approved the appointment of Keith Elison to become and serve as the Company’s Chief Financial Officer, to be effective immediately. Mr. Elison has more than eleven years of experience in public company accounting and SEC compliance and reporting issues. His professional experience includes providing accounting and financial reporting assistance for small and medium-sized publicly held companies.

Tarix Pharmaceuticals Enrolls First Patient in Phase 1 Clinical Study of TXA127 in Adult Patients Following Double Cord Blood Stem Cell Transplant

Tarix Pharmaceuticals today announced enrollment of the first patient in a Phase 1 clinical study of TXA127, a pharmaceutical grade formulation of a naturally occurring peptide known to stimulate early hematopoietic precursor cells in the bone marrow. The study will evaluate the safety of TXA127 following double cord blood stem cell transplant (DCBT) in adult patients with hematological cancers. The study will also compare the time to engraftment for patients receiving TXA127 to that of historical controls in order to assess the efficacy of TXA127 in speeding up the engraftment process.

Umbilical cord blood-derived stem cells offer increased flexibility in the degree of human leukocyte antigen (HLA) matching required for transplantation and are a critical source of donor cells for patients for whom a source of immunologically compatible donor cells are not readily available. Following transplantation, the rate at which the infused stem cells are able to repopulate patients’ blood with platelets and other mature blood cells (engraftment) determines the risk of developing serious complications such as infection and bleeding. There are currently no drugs available that speed up the engraftment process.

“Initiation of our Phase 1 clinical program in DCBT marks another significant milestone in the development of TXA127 for enhancing engraftment following stem cell transplantation,” stated Rick Franklin, CEO of Tarix Pharmaceuticals. “This program complements our ongoing placebo-controlled Phase 2 clinical study in adults receiving autologous peripheral blood stem cell transplant. We are excited to advance these programs in order to address the unmet needs of the full spectrum of patients undergoing hematopoietic stem cell transplants.”

About TXA127

TXA127 is unique because it directly stimulates transplanted stem cells to replenish circulating platelets, white blood cells and red blood cells, potentially reducing the time it takes for blood cell counts to return to safe levels following stem cell transplant, which may accelerate the recovery process and reduce some of the health risks associated with stem cell transplant.

TXA127 was granted Orphan Drug designation from the U.S. Food and Drug Administration (FDA) as a treatment to enhance engraftment in patients receiving a stem cell transplant. TXA127 has also received Orphan Drug designation for the treatment of Myelodysplastic Syndrome (MDS).

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