Ampio Pharmaceuticals, Inc. AMPE -0.74% , a biopharmaceutical company conducting clinical trials on its three lead drugs (Ampion(TM), Optina(TM) & Zertane(TM)), licensing distribution of these drugs and developing additional new drugs, today announced that it is proceeding with the development plan for a combination product to treat both premature ejaculation (PE) and erectile dysfunction (ED). The positive pre-IND meeting in June with the FDA gave the company clear guidance for the two concurrent pivotal trials necessary for approval of Zertane(TM) to treat PE in the USA.Am
Showing posts with label Ampio Pharma. Show all posts
Showing posts with label Ampio Pharma. Show all posts
Ampio Pharmaceuticals Announces the Licensing of Zertane™ to FBM Industria Farmaceutica Ltda to Commercialize in Brazil
Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a company that discovers and develops new uses for previously approved drugs and new molecular entities ("NMEs"), and FBM Industria Farmaceutica Ltda ("FBMFarma"), a member of the HOSPFAR Group that manufactures, imports and distributes pharmaceuticals in Brazil, today announced a license and distribution agreement providing FMBFarma exclusive rights to market Zertane™ in Brazil for the treatment of premature ejaculation (PE). Financial terms were not disclosed at the request of FBMFarma, who will be responsible for obtaining regulatory approval, marketing and distribution in Brazil Michael Macaluso, Ampio's CEO, noted… "As regulatory pathways and cultural attitudes in regards to sexual dysfunction drugs vary from country to country, we believe that optimizing Zertane™ sales around the world would best be accomplished with country and region specific partners, each carefully chosen, and not with a single global partner. Each partner would be required to have a strong presence and be committed to, and capable of, mounting a comprehensive campaign to launch and grow the sales of the product. This criteria led to our recent licensing of Daewong Pharmaceuticals to distribute Zertane™ in Korea. Using the same analysis, in Brazil, it was clear that FBMFarma was the ideal partner for Ampio." Alexandre Ferreira, FBM group's Director of Marketing said... "FBM group expanded into the pharmaceutical business in Brazil 21 years ago. It is a 100% privately owned company with a distribution arm, HOSPFAR, that is ranked among the top 5 distributors in Brazil. HOSPFAR actively sells into both the private and public markets in this country, responding to almost all Brazilian Government tenders.
FBM, the manufacturing branch of the group, is focused on the demand generation, through medical detailing, primarily focused on therapeutic products in the fields of: Urology, Male and Female Hormone Replacement Therapy, Fertility treatment, chemical addiction management and orphan diseases.
FBM group executives are very pleased to establish this partnership with Ampio, since they are extremely confident and enthusiastic about the success that Zertane™ will have in the Brazilian market."
Syndax Pharmaceuticals, a clinical-stage epigenetics oncology company, announced that Arlene Morris has been elected to the board of directors. Ms. M
Ampio Pharmaceuticals, Inc. (NASDAQ: AMPE) ("Ampio" or the "Company"), a developer of innovative proprietary drugs for metabolic, eye, kidney and CNS disease, male sexual dysfunction, and inflammation, today announced the appointment to its Board of Directors of Dr. David R. Stevens as an additional independent director. Dr. Stevens' appointment, effective immediately, brings the number of independent directors on Ampio's board to four out of six board seats. Dr. Stevens is currently executive chairman of Cedus, Inc., a privately-held biopharmaceutical company, and serves on the Board of Directors of Poniard Pharmaceucials, Inc., a public biopharmaceutical company developing and commercializing cancer therapeutics, where he also serves on the Audit and the Nominating and Governance Committees. In addition, Dr. Stevens is a board member of Micro-Imaging Solutions, LLC, a privately held medical device company, and Aqua Bounty Technologies, a biotechnology company listed on the AIM market of the London Stock Exchange. Dr. Stevens formerly served as president and chief executive officer of Deprenyl Animal Health, Inc., a publicly traded veterinary pharmaceutical company, from 1990 to 1998. Dr. Stevens obtained his Ph.D. in comparative pathology from the University of California, Davis, and his B.S. and D.V.M. degrees from Washington State University."On behalf of our board of directors, I would like to welcome Dr. Stevens as our newest board member," said Chief Executive Officer Don Wingerter. "Having personally led and served on the board of directors of a number of biopharmaceutical and medical device companies, Dr. Stevens has a wealth of industry, intellectual property and capital markets experience that our Board believes will prove invaluable as Ampio enters its next stage of growth as a public company."
Subscribe to:
Posts (Atom)
Superhit News
-
US health regulator USFDA has issued a warning letter to German drug firm Fresenius Kabi AG for lapses at its drug manufacturing fac...
-
Goods and Service Tax (GST) is high on the agenda for the new government and its rollout is a priority. GST will benefit the Indian pharma...
-
Rib-X Pharmaceuticals, Inc. announced today the signature of an exclusive worldwide research collaboration agreement and option for license ...
-
Physiomics: Reports difficult trading but highlights growing interest from big pharmaceutical groupsPhysiomics ( LON:PYC ) said that trading conditions were difficult in the six months ended 31 December 2010, but it believes it is in a be...
-
Hindusthan National Glass and Industries Ltd is expected to finalize a strategic overseas acquisition in the pharmaceuticals space in the n...
-
The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey through a written reply in the Lok Sabha informed about th...
-
India's Central Drugs Standard Control Organization (CDSCO) has suspended the manufacturing of eye drops at the Chennai-based firm after...
-
The government is hoping to see the implementation of the track and trace system for domestic and export supply chain in another one y...
-
Diclofenac injection is a painkiller which is manufactured by Themis Medicare Ltd and marketed by Novartis India under the brand name ...
-
Amylin Pharmaceuticals, Inc. AMLN +16.15% and Alkermes plc ALKS +4.61% today announced that the U.S. Food and Drug Administration (FDA) has ...