UPDATED: Mylan's women's health biz leaps to fore in emerging markets with $750M Famy deal
February 2, 2015 - Fierce Pharma
U.S.-based Mylan will pay $750 million in cash to buy women's healthcare businesses from India's Famy Care, vaulting to first place in emerging markets contraceptive sales. With the deal, Mylan gets Famy's range of women's health products, including oral and injectable contraceptives, intrauterine devices (IUDs), tubal rings and hormone-replacement therapies. Four Indian manufacturing plants and 900 employees will also move to Mylan's roster.
Mylan buys into Theravance's COPD contender in $265M deal
February 2, 2015 - Fierce Biotech
Generics giant Mylan is shouldering its way into the blockbuster market for COPD treatments, signing a $265 million deal with the respiratory experts at Theravance Biopharma ($TBPH) to get its hands on a late-stage contender. Under the agreement, Mylan will hand over a $15 million cash payment and make a $30 million equity investment in Theravance, promising $220 million more if the collaboration goes according to plan. In exchange, it will partner up on TD-4208, a once-daily long-acting muscarinic antagonist (LAMA) designed to relieve symptoms of COPD and other respiratory diseases. The drug posted positive top-line results in Phase II, Theravance said, and is on track to begin late-stage trials later this year. Per the deal, Theravance will pay its way through Phase III with Mylan reimbursing its costs up until an FDA filing.
Icon buys MediMedia Pharma Solutions for $120 million
February 2, 2015 - Pharma Times
Ireland-based Icon is to acquire MediMedia Pharma Solutions for $120 million, creating "the industry's leading integrated scientific communications and market access solution". The Yardley, Pennsylvania-based company is a division of MediMedia USA and is being sold by Vestar Capital Partners. The deal includes MediMedia Managed Markets and Complete Healthcare Communications. The former provides "strategic payer-validated market access solutions", while the latter is an agency which works with medical affairs, commercial and brand development teams within life science companies. Icon chief executive Ciaran Murray said "the need to demonstrate and communicate the value of new medicines is an important global healthcare trend" and the acquisition of MediMedia Pharma Solutions "deepens the expertise" of the company's existing operations "and brings us outstanding scientific and medical communications capabilities".
Albertsons, Safeway complete merger
February 2, 2015 - Drug Store News
Albertsons and Safeway announced on Friday that they have completed their proposed merger. Under the terms of the merger agreement first announced in March 2014, Albertsons will acquire all outstanding shares of Safeway. "We plan to be the favorite local supermarket in every community we serve," said Safeway president and CEO Robert Edwards, who becomes president and CEO of the newly combined company, effective immediately. "We will do this by knowing, listening to, and delighting our customers; providing the right products at a compelling value; and delivering a superior shopping experience. We will also continue to be active members of our local communities."
Biotech guru Gregory Verdine lands $18M round for new WaVe drug developer
February 2, 2015 - Fierce Biotech
A U.S./Japanese hybrid biotech chaired and co-founded by Gregory Verdine, the high-profile Harvard investigator now laboring as CEO of Warp Drive Bio, has gathered together $18 million in a transpacific venture round and set its sights on developing a "revolutionary" new class of nucleic acid drugs based on a potentially breakthrough approach to drug design. An increasingly prolific RA Capital Management joined Kagoshima Shinsangyo Sosei Investment to lead the round for WaVe Life Sciences with the original seed investor, SNBL. That money will back an inchoate R&D platform that is based on the scientific insights of Verdine and Japan's Takeshi Wada, from Tokyo University.
Medtronic, Inc. Strikes a Huge Home Health Care Partnership Deal
February 2, 2015 - Device Space
Medtronic plc announced today a partnership agreement between its Cardiocom business and LHC Group, a U.S. provider of home health, hospice and comprehensive post-acute healthcare services, to provide integrated clinical telehealth services and medical technology to their patients. This agreement adds to the growing list of home health care organizations that are now customers of Cardiocom, Medtronic's Patient Monitoring Services business. Four of the five largest home health care companies in the United States are now Medtronic customers. "As more health systems and Accountable Care Organizations look toward maximizing value and population health models, post-acute care providers are playing a critical role in ensuring patients remain healthy through the transition from the hospital to their homes," said Daniel L. Cosentino, vice president and general manager of Medtronic's Cardiocom business. "We are proud to be providing LHC Group, and all of our partners, with easy-to-use telehealth technology and clinical support services to complement their in-home visit of patients to keep them healthy and out of the hospital."
Moody's: Big Pharmas face growing patent-loss threats, but some pipelines are improving
February 3, 2015 - Fierce Pharma
For the past couple of years, the pharma industry has had something of a reprieve from patent-cliff nightmares. But according to Moody's Investors Service, some companies face new threats to their sweet dreams. Five companies-Pfizer, Eli Lilly, Merck, Amgen , and Novo Nordisk --are more threatened by patent losses than they were a couple of years ago, Moody's figures, chiefly because of potential biosimilar competition. But that doesn't mean these companies all face the biggest challenges to their sales. AstraZeneca, Eli Lilly and Bristol-Myers Squibb, meanwhile, are the companies with the most exposure to patent expirations overall, with 30% to 40% of their sales at risk.
Supply chain services firm VHA to merge with UHC
February 3, 2015 - Healthcare Finance
Supply chain management company VHA on Tuesday said it will merge with UHC, creating a single healthcare services company that ranks it among the largest in the nation. The financial terms were not disclosed. The new organization, which has yet to be named, will provide services to close to 30 percent of U.S. hospitals, including nearly all academic medical centers and health systems it said in a statement.
Alliqua Biomedical Snaps Up Celleration, Inc. for $30.4 Million
February 3, 2015 - Device Space
Alliqua BioMedical, Inc., a provider of advanced wound care products, today announced that it has signed a definitive agreement to acquire Celleration, Inc. for an initial purchase price of approximately $30.4 million, which is comprised of both cash and stock. The merger agreement provides for additional contingent payments in stock and cash, under certain circumstances, if stated revenue thresholds are reached over the next two years ending December 31, 2016 or if certain milestones are satisfied in connection with product sales in the U.K. Celleration is a privately held medical device company, based in Eden Prairie, Minnesota, which is focused on developing and commercializing the MIST Therapy� therapeutic ultrasound platform for the treatment of acute and chronic wounds. Celleration's MIST Therapy System is an FDA 510(k) cleared device that uses painless, noncontact low-frequency ultrasound to stimulate cells below the wound bed in order to promote the healing process. Celleration generated total revenue of approximately $8.7 million during its fiscal year ended December 31, 2014. Since Celleration's MIST Therapy System was commercialized in 2005, MIST therapy has been performed more than 1.2 million times on over 85,000 patients in the U.S. and the U.K.
Backed By Eli Lilly, Roche, and Sanofi, Startup Lysosomal Therapeutics Bags $20 Million
February 3, 2015 - Bio Space
Lysosomal Therapeutics Inc. announced today that the company has raised $20 million in Series A financing from existing investors including Lilly Ventures, Roche Venture Fund, Sanofi-Genzyme BioVenture, Atlas Ventures, Hatteras Venture Partners and Partners Innovation Fund. Several new angel investors, including Orion Equity Partners, LLC, and LTI co-founders Henri Termeer and Bob Carpenter, contributed as well. The new funding will support two ongoing initiatives and one new project. The primary beneficiary will be the preclinical development of a glucocerebrosidase (GCase) lysosomal enzyme activator candidate for the treatment of Parkinson's disease. The second will be a biomarker initiative, which began with grant funding from The Michael J. Fox Foundation for Parkinson's Research, that will help the company select patients for future clinical trials. The new project will be research into genetic links between other lysosomal storage disorders and neurodegenerative diseases.
InSite Vision enters into license agreement with Nicox for AzaSite, AzaSite Xtra and BromSite in EMEA
February 3, 2015 - Pharmaceutical Business Review
InSite Vision Incorporated announced that it has entered into a license agreement with Nicox, a France-based publicly traded company, for the development and commercialization of InSite's innovative ophthalmic therapeutic products AzaSite (1% azithromycin), AzaSite Xtra (2% azithromycin) and BromSite (0.075% bromfenac) all formulated in InSite's DuraSite� drug delivery system. The agreement grants Nicox exclusive rights to commercialize all three products in Europe (including Eastern Europe), Middle East and Africa (EMEA). Nicox expects to file European Marketing Authorizations (MAAs) for AzaSite and BromSite by first quarter 2016 with first commercial launch in late 2017.
Helsinn grants Stendhal exclusive rights to distribute and markete NEPA
February 3, 2015 - Pharmaceutical Business Review
Helsinn, the Swiss Group focused on building quality cancer care, and Especificos Stendhal, announced that exclusive rights to NEPA, an oral fixed combination of netupitant and palonosetron developed for the prevention of chemotherapy-induced nausea and vomiting (CINV), have been granted to Stendhal for Mexico, Venezuela, Colombia, Per�, Ecuador and most of Central American countries. NEPA is an oral fixed combination of a novel NK1receptor antagonist (netupitant) and the best-in-class 5-HT3receptor antagonist palonosetron, already approved in the USA with the trade name AKYNZEO for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. NEPA is currently in the registration phase in Europe and will be soon submitted to other regulatory authorities in the territories included in the agreement between Helsinn and Stendhal, for the prevention of CINV.
Valeant is kicking tires at Salix, but a rival Shire bid could quash the idea
February 4, 2015 - Fierce Pharma
After keeping quiet on the M&A front since its failed hostile bid for Allergan, serial acquirer Valeant last week announced its leading bid for the bankrupt Dendreon's assets. Now, it may be ready to strike again. Valeant is talking with its advisers about a potential bid for North Carolina's Salix Pharmaceuticals, which is struggling to get its act together after an inventory snafu overstated sales and sent its CFO packing, Bloomberg reports. The way Sterne Agee analyst Shibani Malhotra sees it, Salix could cost the Canadian pharma upward of $170 per share. Salix's lead product, Xifaxan, up for an IBS indication from the FDA, has "significant growth potential," Malhotra figures. Add the potential synergy for buyers focused on GI meds, or a tax advantage like Valeant's, and that's worth "at least a 20% premium to our standalone $145 valuation," she wrote in a note to investors.
Bone Therapeutics IPO raises 32.2 million euros
February 4, 2015 - Pharma Times
Belgian cell therapy specialist Bone Therapeutics has raised 32.2 million euros in a heavily-oversubscribed initial public offering. The IPO, on the Euronext exchanges in Brussels and Paris, was priced at 6.00 euros per share, giving the Gosselies-based ompany a market capitalisation of 104.8 million euros. Chief executive Enrico Bastianelli noted that the firm has been backed by "more than 50 new high quality European institutional and private investors".
Ligand, Sermonix ink license deal for lasofoxifene
February 4, 2015 - Pharmaceutical Business Review
Ligand Pharmaceuticals Incorporated announces the signing of a license agreement with Sermonix Pharmaceuticals for the development and commercialization of oral lasofoxifene in the United States and additional territories. Under the terms of the agreement, Ligand has received an undisclosed initial payment, and is entitled to receive up to $45 million in potential regulatory and commercial milestone payments and tiered royalties of 6% to 10% on future net sales. Lasofoxifene is an estrogen partial agonist for the treatment of osteoporosis and other diseases. "Lasofoxifene has a promising profile and a large clinical dataset, and we are excited to see development of the oral form move forward in additional territories," commented John Higgins, Chief Executive Officer of Ligand.
MicroConstants leverages Chinese Academy of Sciences antibody rights in license deal
February 4, 2015 - Fierce Biotech
CRO MicroConstants China has signed a licensing agreement to gain the global rights for the development of AA98 antibody drug candidates from the Institute of Biophysics of the Chinese Academy of Sciences in a unique deal between academia and local industry. These AA98 antibody drug candidates are used for treating multiple sclerosis, various types of cancer and age-related macular degeneration. MicroConstants China will bear all the development costs. Upon successful development and global marketing and sales of the AA98 antibody derived drugs, the Institute of BioPhysics (IBP) is likely to receive upfront and milestone payments of more than RMB 100 million ($62 million), plus royalty payments.
AstraZeneca to Buy Actavis' Respiratory Drug Business in U.S., Canada
February 5, 2015 - The Wall Street Journal
AstraZeneca PLC on Thursday moved to further bulk up its respiratory drug business with the acquisition of Actavis PLC's branded respiratory drug business in the U.S. and Canada for an initial $600 million. Under the deal, the U.K. drug maker will be able to sell Actavis's Tudorza Pressair and Daliresp-both chronic obstructive pulmonary disease drugs-in the U.S. and Canada. The products generated combined annual sales in the U.S. of around $230 million last year. AstraZeneca will also own development rights for a therapy for the same condition in the U.S. The product is already approved in the European Union.
Cancer Drug Developer G1 Therapeutics Closes $33M Series B Round
February 5, 2015 - Xconomy
G1 Therapeutics CEO Mark Velleca knows that three large pharmaceutical companies are researching the same cancer target as his tiny startup. But even though Velleca concedes those companies are ahead for now, he believes G1 can eventually stand out against those bigger, better-financed counterparts by taking a different approach. Now the Research Triangle Park, NC-based company has some additional cash to try to prove it. G1 plans to announce Thursday the closing of a $33 million Series B round of financing that the company will use to study its experimental drug in additional clinical trials. Eshelman Ventures and RA Capital Management led the round, joined by new investors Lumira Capital and Boxer Capital of Tavistock Life Sciences. Existing investors Hatteras Venture Partners, MedImmune Ventures, and Mountain Group Capital also participated in the round.
Armetheon raises $24M to get its anticoagulant into Phase III
February 5, 2015 - Fierce Biotech
Menlo Park, CA's Armetheon raised a $24.3 million B round to support work on a new oral blood thinner the biotech believes can fill a hole in the blockbuster anticoagulant market. The drug, tecarfarin, works by blocking an enzyme called VKOR that plays a role in blood clotting. In its Phase II trials, the tablet has so far avoided the side effects common in standard-of-care warfarin, Armetheon said. And the company believes it can make a meaningful difference for patients with prosthetic heart valves, a group often ineligible for next-generation drugs like Xarelto and Eliquis. Now, with new cash from a syndicate including Hercules Bioventure Partners and Capital TEN II, the biotech is planning a 3,000-patient Phase III trial to prove tecarfarin's worth. Armetheon plans to test the drug against warfarin to see which if it can better help patients stay in the target range of anticoagulation, in which blood takes about two to three times as long to clot as it would normally.
Pfizer's still a likely buyer after its $17B 'hors d'oeuvre'
February 6, 2015 - Fierce Biotech
A few months ago, Pfizer had $33 billion in cash and a yen for dealmaking, with CEO Ian Read scouting for acquisitions that create value "in the near term." Now, after signing up to acquire Hospira for $17 billion, the company is just getting started, analysts say, pointing to Pfizer's failed quest for AstraZeneca as evidence that the drugmaker is looking for some transformational M&A. As Bloomberg reports, the Hospira buyout will give Pfizer a needed jolt in its established products business and a bigger share of the soon-to-explode market for biosimilars. That checks off a few of those near-term needs Read identified, but Hospira is no AstraZeneca, and Pfizer's prior interest in a huge deal suggests it will soon go back to the buyout well.
Provenge in a dish not yet sold: Valeant ups Dendreon offer after competing bids
February 6, 2015 - Outsourcing Pharma
Bankrupt cell therapy firm Dendreon has attracted more suitors according to stalking horse bidder Valeant, which upped its offer for the Provenge (sipuleucel-T) developer to $400m this week.
RXi Pharma closes licensing deal with Hapten for Samcyprone
February 6, 2015 - Pharmaceutical Business Review
US-based biotechnology firm RXi Pharmaceuticals has closed its exclusive global license agreement for the therapeutic use of Samcyprone with Hapten Pharmaceuticals. As part of the deal, Hapten received a one-time upfront cash payment of $100,000 and 200,000 shares of RXi common stock. Hapten will also be eligible to receive future milestone payments tied to the achievement of certain clinical and commercial objectives, such as first patient enrollment in a Phase III trial and regulatory approval, as well as escalating royalties based on product sales.