March 9, 2015 - Bio Space

Pennsylvania-based Recro Pharma announced Monday morning it has acquired the pain medication meloxicam IV/IM and a manufacturing facility in Gainesville, Ga. from Dublin, Ireland-based Alkermes plc in a $170 million deal. Meloxicam IV/IM is a proprietary, Phase III-ready, long-acting COX-2 NSAID used to target moderate to severe acute pain. Meloxicam IV/IM is a nonsteroidal anti-inflammatory drug... In five phase II studies treating more than 700 patients with acute pain, meloxicam IV/IM demonstrated positive effect on treating rapid onset of pain relief and" time to peak" analgesic effect, 18 to 24 hour duration of pain relief as well as favorable tolerability.

March 9, 2015 - Fierce Pharma

As AbbVie's $21 billion deal to buy Pharmacyclics shows, drugmakers aren't scared to shell out for cancer drugs--and they're not worried about pricing pressure holding their purchases back. Could PD-1 pioneer Bristol-Myers Squibb be next? Some analysts say it could. Many pharma-watchers see Bristol-Myers' checkpoint inhibitor Opdivo as the leader in immunotherapy--and that's a $40 billion market, according to Leerink Partners estimates. Opdivo already scored its second FDA approval, in record-breaking time, and Bristol could quickly expand the drug beyond its current melanoma and lung-cancer nods. With potential approvals in kidney, bladder, and head and neck cancers, Opdivo could vault beyond the $6 billion-plus in peak sales analysts already expect.

Endo confirms $11bn bid for Salix 

March 11, 2015 - Pharma Times

Endo International has swooped in with an offer for Salix Pharmaceuticals of around $11 billion, overshooting Valeant's $10.4-billion-bid. Endo has confirmed that it is proposing to snap up Salix in a cash and stock deal valuing the firm at $175 per share, while Valeant's deal was based on $158 a share. If its bid is successful, Endo says the transaction could close in the second quarter, and that it is confident of obtaining any regulatory and shareholder approvals.

March 11, 2015 - Fierce Pharma

Rumors have been floating around for months that pickup-hungry Teva may be looking to buy generics competitor Mylan. Some analysts have dismissed the idea, pointing to reasons a buyout wouldn't work. But with the deal talk persisting, at least one analyst says the underlying logic for a tie-up is sound--as long as it doesn't happen right away. As Bernstein's Ronny Gal put it in a note to investors Wednesday, "combining the two companies is reasonable." First off, there's potential for substantial cost synergies in manufacturing and R&D--about $1.2 billion, he figures. Teva in particular has been working to cut down on manufacturing costs, and Mylan's base in India "would certainly help that," he noted. Teva has also been hyping a return to its generic roots. Last quarter, the Israeli pharma's generics revenue fell 8% to $2.47 billion, propelling a 4.8% overall sales drop. Total generics sales took a dip during full-year 2014, too. But adding Mylan, another top-5 copycat drugmaker, would give that business a boost.

AbbVie, Johnson & Johnson Tempted to Take Over $650 Million Galapagos 

March 11, 2015 - Bio Space

Filgotinib, an arthritis medication developed by Belgian drugmaker Galapagos NV is attracting the attention of pharmaceutical giants AbbVie and Johnson & Johnson, Bloomberg reported Tuesday. Filgotinib, also known as GLPG0634, is being developed to treat a number of inflammatory diseases including rheumatoid arthritis. Both AbbVie and Johnson & Johnson currently have stakes in Galapagos, but if the new arthritis drug pans out, the companies may fight to acquire Galapagos, especially since both companies will be losing patent protection on their own arthritis medications, Humira and Remicade. Humira makes up more than half of AbbVie's revenue. In February, Galapagos, a $650 million Belgian drugmaker, completed the first half of a two-part 24-week clinical trial testing Filgotinib. The DARWIN 1 trial tested 599 patients with moderate to severe rheumatoid arthritis who did not respond well to methotrexate. Select patients received Galapagos' medication is administered in pill form, unlike Humira and Remicade, which are administered in a shot.

March 11, 2015 - Outsourcing Pharma

With operations in more than 100 countries, the world's largest CRO Quintiles is now looking to extend its global reach even farther, CEO Tom Pike told investors at the Barclays Global Healthcare Conference on Tuesday.

March 11, 2015 - Device Space

Brookhaven Medical, Inc., has announced the acquisition of FutureMatrix Interventional and CreatiVasc Medical, Inc., in a deal that further facilitates collaboration on a medical device aimed at reducing complications during dialysis treatment for the more than 400,000 dialysis patients in the United States. "These are two premier medical device companies with great management and engineering teams," said Brookhaven Medical CEO John Feltman. "As a major investor in CreatiVasc's research and development since 2013, we are pleased to welcome CreatiVasc and FutureMatrix to the Brookhaven family. Medical advancements on the part of both companies support Brookhaven's mission of embracing innovation to improve clinical outcomes resulting in cost savings for the healthcare system." FutureMatrix and CreatiVasc have collaborated for two years to develop an advanced balloon technology, key to the CreatiVasc Hemoaccess Valve System�. This device allows the flow of blood in an AV graft to be turned on and off between dialysis sessions.

March 11, 2015 - Device Space

VENITI, Inc., a St. Louis, MO-based medical device company is pleased to announce that it has closed on an equity and debt financing totaling over $17 million. The equity portion, its Series C, was led by previous investors, Baird Capital and Tekla Healthcare and Tekla Life Science Investors, with strong internal participation. The senior secured debt portion was funded by Life Sciences Alternative Funding, a New York-based direct investment company.     Steve DeNelsky, President of Life Science Alternative Funding added: "VENITI's VICI VENOUS STENT addresses a large market need with the first technology designed specifically for the vascular system. This design delivers critical advantages, such as crush resistance and flexibility, which we believe physicians will value and lead to better patient outcomes. LSAF is pleased to partner with VENITI during this exciting growth phase."

FDA Leans on Another Compound Pharmacy for Manufacturing Problems 

March 12, 2015 - The Wall Street Journal

Once again, the FDA has taken a tough stance against a compound pharmacy with quality-control problems that led to product recalls and concerns over patient safety. In this latest instance, the agency obtained a consent decree that prohibits Specialty Compounding from making or distributing injectable sterile medicines until the company complies with federal law governing manufacturing practices. The move comes after FDA inspectors found unsanitary conditions, bacterial contamination and numerous manufacturing violations at the compounder. The inspection stemmed from complaints by two hospitals that 17 patients developed infections after being treated with medicines made by the compounder. The compounder recalled the medicines and vowed to correct the problems.

March 12, 2015 - Bio Space

Cambridge, Mass.-based Epizyme said Thursday that it will buy back all commercial rights outside of Japan to its former cancer drug candidate EPZ-6438 from Eisai Company, Ltd. for $40 million up front, plus another possible $70 million in various clinical and regulatory milestones. Epizyme CFO Andrew Singer told analysts on a conference call Thursday that Eisai has paid $39 million in development costs for EPZ-6438, but added that because the company saw how successful the drug was at treating various forms of cancer, the buyback was a solid deal. The ability to control its own destiny has remained an important part of Epizyme ethos, close watchers of the company said of the news Thursday.

March 12, 2015 - Fierce Biotech

Ember Therapeutics, a Third Rock Ventures-founded biotech startup that closed its doors late last year, is getting a second chance thanks to a small New York drug developer. Mariel Therapeutics, which came on the scene last year with some assets acquired from Stryker, is merging with Ember to get its hands on the biotech's intellectual property. Neither side is disclosing financial details, but the plan is to carry on under the Ember moniker, pooling the two companies' assets into a pipeline focused on cartilage- and fibrosis-related diseases. Ember, a 2012 Fierce 15 honoree, got off the ground more than three years ago with a $34 million commitment from Third Rock and a decorated team of scientists planning to investigate the therapeutic potential of calorie-burning brown fat. However, as Luke Timmerman first reported last month, the company quietly shut down in December after struggling to find the partners it needed to move forward in obesity and diabetes, expensive pursuits for a venture-backed biotech. Founding CEO Lou Tartaglia had departed over the summer to lead the RNAi-focused Solstice Biologics, leaving Third Rock to figure out what to do with Ember's intellectual property, Timmerman reported.

AstraZeneca PLC-Backed PhaseBio Locks in $40 Million 

March 12, 2015 - Bio Space

PhaseBio Pharmaceuticals, Inc. , a biopolymer-based drug manufacturer, announced today that it has raised $40 million in a Series C round of funding, led by AstraZeneca PLC. Existing investors New Enterprise Associates, Hatteras Venture Partners and Johnson & Johnson Innovation also participated in the financing round. "The investment from AstraZeneca, together with our existing investors, provides PhaseBio with a great deal of operational flexibility and resources to advance PE0139 into a Phase IIa study, as well as to initiate Phase IIa trials of PB1046 for acute heart failure and for cardiomyopathy in Duchenne and Becker muscular dystrophy patients," said Jonathan Mow, Chief Executive Officer of PhaseBio. "Given the broad potential for PB1046 to treat both heart failure and orphan diseases, we have the flexibility to either develop and launch the product on our own or in collaboration with a partner." JJDC and Fletcher Spaght Ventures will help PhaseBio further its progress on PE0139, a once-weekly insulin treatment for type 2 diabetes. Additionally, PhaseBio will be able to work on PB1046, its once-weekly Vasoactive Intestinal Peptide. The company has been aiming to conduct two separate Phase IIa trials for heart failure and cardiomyopathy with the product.

March 12, 2015 - Pharmaceutical Business Reivew

Japan-based Takeda Pharmaceutical has transferred its license agreement with the Japan Health Sciences Foundation (HS Foundation) for worldwide patent rights of a human papillomavirus (HPV) vaccine (HPV vaccine) to the Chemo-Sero-Therapeutic Research Institute (Kaketsuken). In October 2010, the Japanese firm entered into an agreement with the Japan Health HS Foundation for the development of the HPV vaccine to prevent cervical cancer. Subsequently, the company had conducted preclinical development of the vaccine candidate. After transfer of the license agreement, Kaketsuken will continue research efforts to support future commercialization of the HPV vaccine.

March 12, 2015 - Pharmaceutical Business Review

US-based biotechnology firm Transgenomic has signed an amended license agreement with Denmark's Exiqon for the expansion of rights to their Locked Nucleic Acid (LNA) oligonucleotides. LNA oligos offer dramatically improved sensitivity and specificity compared to traditional DNA chemistries. The amended agreement provides the company with access to LNA oligos for use with all of its ultra-high sensitivity mutation enrichment technologies, including its Multiplexed ICE COLD-PCRTM (MX-ICP). The deal also covers the company's commercial worldwide use of LNA oligos for analysis of all cancer genes on all platforms, including cutting edge approaches such as next-generation sequencing (NGS).

Newly beefed-up Par Pharma files for an IPO
March 13, 2015 - Fierce Pharma
Par Pharmaceutical has bulked up quite a bit recently, and now it's ready to go public. The New Jersey company, owned by private equity outfit TPG Capital, has filed with the SEC for an IPO. While Friday's S-1 did not include how many shares Par planned to sell or what their expected price would be, last month, Reuters reported that the company could raise around $500 million with a public offering, which could value the drugmaker at $3 billion to $4 billion.  

Here's How to Size Up Rival Bids for Salix
March 13, 2015 - The Wall Street Journal
In bidding wars like the one that has developed over Salix Pharmaceuticals Ltd., whoever offers the most usually wins. Determining who's the high bidder in this case may be harder than it seems.   

March 13, 2015 - Device Space
San Diego-based Accriva Diagnostics, a maker of point-of-care tests for strokes and other cardiovascular conditions, just raised about $15.5 million in equity, according to a regulatory filing. It's got a number of products - an anticoagulation monitoring system called Hemochron, a test that measures a patient's platelet reactivity to antiplatelet meds, a heelstick device for newborns and several others. One of its devices, the InRhythm, isn't yet FDA approved - the rest are.