Horizon Pharma's Actimmune Gets Fast Track Status – Analyst Blog

Horizon Pharma plc HZNP announced that the FDA has granted fast track status to Actimmune for the treatment of Friedreich’s ataxia. Actimmune is already approved in the U.S. for the treatment of patients suffering from two rare diseases – chronic granulomatous disease and severe, malignant osteopetrosis.

Currently, Horizon Pharma is working toward expanding the product’s label in additional indications.

Fast track designation is granted to candidates that are being developed for the treatment of a serious or life-threatening disease or condition and is believed to possess the capability to address unmet medical needs. On receiving this designation, Horizon Pharma may communicate with the FDA frequently throughout the entire development and review process, with the aim of expediting the candidate’s approval. Moreover, the company is also eligible to make a rolling submission of new drug application for the candidate, which will be considered for priority review.

Horizon Pharma intends to commence a randomized, double-blind, multi-center, placebo-controlled phase III study on Actimmune in the second quarter of 2015 for the treatment of Friedreich’s ataxia in patients aged between 10 and 25 years. The primary endpoint for the study will measure the change from baseline in the patients after 26 weeks of treatment with ACTIMMUNE compared to placebo. The study will be conducted in collaboration with the Friedreich’s Ataxia Research Alliance (FARA) and a sub-set of FARA’s Collaborative Clinical Research Network study centers. Actimmune enjoys orphan drug designation in the U.S. for Friedreich’s ataxia.

According to the company, there are no therapies approved by the FDA for the treatment of Friedreich’s ataxia. Given that one in 50,000 people in the U.S. suffer from the disease, there is strong unmet need for drugs in the treatment of Friedreich’s ataxia.

Horizon Pharma carries a Zacks Rank #1 (Strong Buy). Other well-ranked stocks in the health care sector include ANI Pharmaceuticals, Inc. ANIP, Cytokinetics, Incorporated CYTK and Acorda Therapeutics, Inc. ACOR. All these stocks carry the same rank as Horizon Pharma.

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Source Article from http://finance.yahoo.com/news/horizon-pharmas-actimmune-gets-fast-175005268.html
Horizon Pharma's Actimmune Gets Fast Track Status – Analyst Blog
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TVM Life Science Ventures VII Announces Investment in Esperas Pharma Inc.

MONTRÉAL, April 13, 2015 /CNW Telbec/ - TVM Life Science Ventures VII today announced the fund’s seventh investment, a co-investment with the Fonds de solidarité FTQ (the “Fonds”) – establishing Esperas Pharma Inc., a company based in Montréal, Québec. Esperas Pharma Inc. plans to develop, to proof-of-concept, a compound originally discovered through one of Eli Lilly and Company’s (Lilly) research and development programs, with the potential to treat certain types of cancers including triple negative breast cancer.  

“The management team of Esperas Pharma Inc. is delighted to have the opportunity to collaborate with the TVM Capital Life Science team to develop a biopharmaceutical asset to clinical proof-of-concept,” said Caroline Fortier , CEO of Esperas Pharma Inc.

“This direct investment by the Fonds de solidarité FTQ shows our desire to bring to Québec the economic benefits of new partnering models between funds, large pharmaceutical companies and biotech companies,” said Alain Denis , Senior Vice-President, New Economy of the Fonds de solidarité FTQ.

Esperas will be initiating the first human dose study in multiple types of cancers. Cohort expansions are planned in several different tumors, including triple negative breast cancer. Triple negative breast cancer (TNBC) refers to a tumor type that is negative for the receptors for progesterone and estrogen as well as being negative for Her2/Neu making this type of tumor particularly difficult to treat. TNBC constitutes about 10-20% of all breast cancers which, in the U.S., is the most common cancer amongst women. According to breastcancer.org ( March 2015 ), one in eight women will develop invasive breast cancer with more than 232,000 new cases per year. In addition to TNBC, Esperas Pharma will explore the development of this anti-cancer agent in other solid tumor types that continue to be poorly served by currently approved treatments.

“TVM Capital Life Science is proud to have enabled the creation of Esperas Pharma Inc., and to have secured the rights to a compound that specifically inhibits cancer cell division or unchecked proliferation. This transaction is a testament to the benefits of our investment model,” said Dr. Luc Marengere , Managing Partner with TVM Capital Life Science. “Furthermore, we are pleased to collaborate with Caroline Fortier and Mark Cipriano , who will act as CEO and CFO respectively for Esperas Pharma Inc. Caroline has had a longstanding career in the life science industry; Mark is a well-known CFO in the industry.”

This is the seventh investment for TVM Life Science Ventures VII, a venture capital fund domiciled in Montréal, Québec, which follows a new, capital-efficient investment approach to developing pharmaceutical assets to human proof-of-concept in single-asset companies. TVM Life Science Ventures VII is a unique collaboration between TVM Capital Life Science and Lilly to finance and access innovation beyond Lilly’s walls and as a way to manage risk and share reward.

Esperas Pharma Inc. will leverage its extensive product development expertise to potentially bring its asset to human proof-of-concept. If and when proof-of-concept is reached, Lilly will have an opportunity to acquire the molecule.

“TVM Life Science Ventures VII is an important part of our strategy as we strive to identify, access, and shape innovation in areas of unmet medical need, like oncology,” said Darren Carroll , Lilly’s senior vice president of corporate business development. “Lilly’s alternative risk-sharing approach has allowed us, together with other investors, to support the creation of project-focused companies, speeding the delivery of timely valued medicines to patients who are waiting.”

“Beyond its investment in the fund, Lilly’s relationship with TVM Capital Life Science makes its clinical-development expertise available to the resulting project-focused companies, including Esperas Pharma Inc., which will support these companies’ efficiency and cost-effectiveness in reaching clinical proof-of-concept,” said Dr Luc Marengere .


About TVM Capital Life Science
TVM Capital Life Science is providing venture capital to the international pharmaceutical, biopharmaceutical and medical technology industries with more than 25-years of transatlantic investment track record and in excess of US$1.1bn under management. The life science team boasts more than 120 investments and almost 90 exits in the last 25 years, including more than 40 initial public offerings on all major U.S. and European stock exchanges, and combines long-standing international investment and company building experience with their track record of dedicated board work, extensive global networks in the world of life science research and product development and a direct knowledge of the local markets. TVM Capital Life Science currently invests from its 7th fund generation, TVM Life Science Ventures VII, with an integrated team of investment professionals. Fund generations III to VI are managed by Managing Partners, Dr. Helmut M. Schühsler and Dr. Hubert Birner out of the Munich office. The new fund TVM LSV VII is advised by Dr. Hubert Birner and Dr. Luc Marengere out of Montreal .
www.tvm-capital.com or www.tvm-lifescience.com

About TVM Capital
TVM Capital is a group of globally acting venture capital and private equity firms with an operating track record of 30 years. Investment teams have financed more than 250 emerging companies across several industries since 1984. During the last 15 years the firm has become increasingly specialized in the most attractive and high-growth verticals in the broader healthcare markets, with focus areas in financing innovative products and technologies in the European and U.S. biopharmaceutical and medical device markets, as well as healthcare services in the Middle East and India . TVM Capital funds operate globally with dedicated Life Science venture capital funds advised by group members TVM Life Science Management in Montréal and TVM Capital in Munich , and its healthcare private equity fund managed by TVM Capital MENA out of Dubai .

About the Fonds de solidarité FTQ
With net assets of $10.5 billion as at November 30, 2014 , Fonds de solidarité FTQ (www.fondsftq.com) is a development capital fund that calls on the savings of Quebecers to help drive economic growth in the province. It partners with over 2,450 businesses, either directly or through members of its network, and its investments in all spheres of activity serve to create and safeguard over 172,000 private sector jobs. Over 600,000 shareholders are invested in the fund

About Esperas Pharma Inc.
Esperas Pharma Inc. is a special purpose company created to develop one compound to proof-of-concept. The project is fully financed by TVM Life Science Ventures VII and Fonds de solidarité FTQ (the “Fonds”). To date, the biopharmaceutical asset has completed GLP toxicology studies. Esperas Pharma Inc. plans to begin clinical development as early as Q1-2016. Once cleared for clinical development by regulatory authorities, the Esperas Pharma Inc. compound will be tested directly alone and in combination with gemcitabine in women with triple-negative breast cancer. Later on, the compound may be tested in one of a number of additional cancer indications with the goal of providing a clinical proof-of-concept of efficacy for cancer patients. Esperas Pharma Inc. is funded by TVM Life Science Ventures VII and the Fonds, and is led by an experienced management team.

This press release contains forward-looking statements about TVM Life Science Ventures VII and Lilly’s investment in a pre-clinical stage compound for the treatment of certain types of cancers that is being developed by Esperas Pharma Inc. It reflects Lilly’s and TVM’s current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development. There is no guarantee Lilly will realize the expected benefits of the transaction, that the product will receive regulatory approval, or if approved, would be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly’s latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. The companies undertake no duty to update forward-looking statements.

General Partner
TVM Life Science Ventures VII (GP) Ltd.
11-15 Seaton Place ,
St Helier, Jersey
JE4 0QH, Channel Islands

Investment Advisor
TVM Life Science Management Inc.
2 Place Alexis Nihon, Suite 902
3500 Blvd De Maisonneuve West, Westmount ,
Montréal, QC H3Z 1X5 Canada


SOURCE Fonds de solidarité FTQ

Dr. Luc Marengere, Managing Partner, TVM Capital Life Science: marengere@tvm-capital.com, Phone: 514-931-4111; Dr. Hubert Birner, Managing Partner, TVM Capital Life Science: birner@tvm-capital.com, Phone: 514-931-4111; Caroline Fortier, CEO, Esperas Pharma Inc.: mailto:caroline.fortier@esperasinc.com; Patrick McQuilken, Senior Advisor, Media Relations and Communications, Fonds de solidarité FTQ: pmcquilken@fondsftq.com, Phone: 514-850-4835

Source Article from http://finance.yahoo.com/news/tvm-life-science-ventures-vii-144700034.html
TVM Life Science Ventures VII Announces Investment in Esperas Pharma Inc.
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Recro Pharma Completes Acquisition of IV/IM Meloxicam and cGMP Manufacturing Facility and Business Unit From Alkermes

- Transformative Acquisition Diversifies Recro Pharma’s Development Risk with Second, Complementary Acute Pain Product

- Phase III-Ready, Long-Acting Injectable Meloxicam Has Demonstrated Robust Efficacy, Good Tolerability in Multiple Phase II Trials

- Transaction Includes Cash Flow Positive Manufacturing, Royalty and Formulation Business

MALVERN, Pa., April 13, 2015 (GLOBE NEWSWIRE) — Recro Pharma, Inc. (REPH) today announced the completion of its previously announced acquisition of assets from Alkermes plc and its affiliates including worldwide rights to IV/IM meloxicam, a proprietary, Phase III-ready, long-acting COX-2 NSAID for moderate to severe acute pain, and a contract manufacturing facility, royalty and formulation business.

“Completion of this transaction is a significant corporate milestone for Recro Pharma as it provides a second, complementary, Phase III-ready acute pain product to our portfolio, and adds infrastructure and cash flow which may help fund the development of our pipeline in the future,” said Gerri Henwood, Recro Pharma’s CEO. “With upcoming top-line data readout of our Post Op Day 1 Phase II trial of Dex-IN mid-year 2015, we are excited for the potential of having two drug candidates in Phase III for the treatment of acute pain by the end of this year.”

Under the terms of the agreement, Recro Pharma paid Alkermes $50 million up-front and obtained the rights to IV/IM meloxicam and ownership of a cGMP manufacturing facility and related business located in Gainesville, GA. In 2014, this facility generated over $70 million in unaudited revenues. Alkermes is eligible to receive up to an additional $120 million in milestone payments upon the achievement of certain regulatory and net sales milestones and royalties, related to IV/IM meloxicam. At closing, Recro Pharma issued Alkermes a seven-year warrant to purchase an aggregate of 350,000 shares of Recro Pharma common stock. The $50 million up-front payment was funded via a five-year senior secured term loan with an affiliate of OrbiMed (“OrbiMed”). In conjunction with the term loan, Recro Pharma issued OrbiMed a seven-year warrant to purchase an aggregate of 294,928 shares of Recro Pharma common stock.

About Recro Pharma, Inc.

Recro Pharma is a revenue generating specialty pharmaceutical company developing multiple non-opioid therapeutics for the treatment of acute post operative pain. Recro Pharma is currently developing IV/IM meloxicam, a proprietary, Phase III-ready, long-acting COX-2 NSAID, and Dex-IN, a proprietary intranasal formulation of dexmedetomidine in Phase II, for the treatment of acute pain. As Recro Pharma’s product candidates are not in the opioid class of drugs, the Company believes its candidates would avoid many of the side effects associated with commonly prescribed opioid therapeutics, such as addiction, constipation and respiratory distress while maintaining analgesic effect.

As a result of this acquisition, Recro Pharma also owns and operates an 87,000 square foot, DEA-licensed facility that manufactures 5 commercial products and receives royalties associated with the sales of these products.

Cautionary Statement Regarding Forward Looking Statements

This press release contains forward-looking statements that involve risks and uncertainties. Such forward-looking statements reflect Recro Pharma’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to Recro Pharma or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information available to Recro Pharma as of the date of this press release and are subject to a number of risks, uncertainties, and other factors that could cause actual events to differ materially from those expressed in the forward-looking statements set forth in this press release including, without limitation: the success of Recro’s products and of the newly acquired products; the parties’ ability to satisfy the purchase agreement conditions (including required regulatory approvals); Recro’s ability to realize anticipated growth, synergies and costs savings from the acquisition; changes in laws and regulations; Recro’s ability to successfully integrate the acquired operations, technology and products and to realize anticipated growth, synergies and cost savings; Recro’s ability to successfully develop, obtain regulatory approvals or commercialize new products and Recro’s ability to protect intellectual property rights. In addition, the forward-looking statements in this press release should be considered together with the risks and uncertainties that may affect Recro Pharma’s business and future results included in Recro Pharma’s filings with the Securities and Exchange Commission at www.sec.gov. Recro pharma assumes no obligation to update any such forward looking statements.

Source Article from http://finance.yahoo.com/news/recro-pharma-completes-acquisition-iv-110000445.html
Recro Pharma Completes Acquisition of IV/IM Meloxicam and cGMP Manufacturing Facility and Business Unit From Alkermes
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