February 9, 2015 - Bio Space

Pulmonary disease startup SteadyMed will raise up to $55 million for an initial public offering, the company said in a filing with the U.S. Securities and Exchange Commission Friday, as it attempts to bring its orphan drug therapy to a wider, more lucrative audience. No pricing terms were disclosed. SteadyMed is developing a combination therapy and pump for pulmonary arterial hypertension (PAH), an orphan disease, via main candidate, Trevyent. Trevyent is a cocktail of treprostinil and SteadyMed's PatchPump, a water-resistant and disposable drug administration technology, pre-filled with the liquid drug programmed to deliver the drug over 48 hours.

February 10, 2015 - The Wall Street Journal

Over the past year or so, the pharmaceutical industry has tried to leave the patent cliff behind and persuade investors to focus on their product pipelines. But sorting out which drug makers are most likely to capitalize as they grapple with generic competition and seek regulatory approvals can be difficult. In a bid to provide some clarity, Moody's Investors Services examined the pipelines and looming patent expirations at 16 large drug makers and, not surprisingly, found that some are doing better than others. Of course, direct correlations can be hard to come by - just because a drug maker has a strong pipeline does not mean the same company does not also face a notable patent expiration.

February 10, 2015 - Pharma Times

Roche has hit the acquisition trail again to buy privately-held Signature Diagnostics of Germany. The Potsdam-based firm is a translational oncology and genomics company that develops large blood plasma and tissue biobanks in multiple cancers, including colorectal and lung. Signature uses the samples from its biobanks along with accompanying clinical progression and genetic data to develop and validate circulating cell free DNA (cfDNA) tests.

February 10, 2015 - Pharmaceutical Business Review

BioPharma Services is pleased to announce it has entered into a partnership and joint venture agreement with Scentryphar, a leading CRO located in Sao Paulo. The partnership will support local and global sponsors looking to bring generic and innovative drugs to the Brazilian market by offering one stop shopping and joint expertise in clinical conduct, bioanalysis, data management, statistics as well as scientific and medical writing. "We are extremely pleased to partner with Scentryphar to offer generic and Phases I-IV project management for Brazilian submission. This strategic alliance will allow our sponsors to bring products in Brazil in a timely fashion while maintaining high quality standards," said Mr. Renzo DiCarlo, CEO at BPSI. "We are honoured to partner with BPSI which has a great international reputation in the industry and with many regulatory agencies including US FDA, Health Canada and EMA. Working with BPSI will position both companies as leading CRO's in Brazil," said Dr. Eduardo Abib Jr., President and Chief Executive Officer at Scentryphar.

February 11, 2015 - Bio Space

Laval, Quebec-based Valeant Pharmaceuticals International, Inc. announced yesterday that its $400 million cash bid for bankrupt Seattle-based Dendreon Corporation assets has won. On Jan. 29, 2015, Valeant announced that it had made a "stalking horse" bid of $296 million for assets of Dendreon Corporation. A stalking-horse bid is an initial floor bid that creates a low threshold in order to avoid low bids on assets. Dendreon announced bankruptcy on Nov. 10, 2014. Part of the Chapter 11 agreement allowed the company to continue selling its prostate cancer drug Provenge.

February 11, 2015 - Bio Space

Cambridge, Mass.-based Voyager Therapeutics announced today a collaboration agreement with Boston-based Genzyme Corporation to develop therapeutics for the treatment of severe CNS disorders. What brings the two companies together is a strong background in gene therapy research. Genzyme has depth in adeno-associated virus (AAV) gene therapy. Voyager's major platform is a "Product Engine" that focuses on AAV process development, production, optimization and engineering. The collaboration will focus on multiple gene therapy programs, including for Parkinson's disease, Huntington's disease and other CNS disorders. Genzyme will bring in $100 million upfront, including $65 million in cash and a $30 million equity investment in Voyager. Voyager has the possibility of receiving up to $745 million in future milestone payments and royalties.

February 11, 2015 - Bio Space

GlaxoSmithKline has finally gone all in and acquired the rest of Swiss specialist vaccine company GlycoVaxyn for $190 million, after holding a minority stake in the company since 2012. GlyxoVaxn's portfolio includes a host of early stage vaccines aimed at inoculation against infections including pneumonia, pseudomonas, staphylococcus aureus and shigellosis. The company's renewed interest in GlycoVaxyn comes as the world's debate about vaccines intensifies and Glaxo continues to look for bolt-on acquisitions that will beef up its vaccine portfolio. As such, Glaxo said in a statement it is looking to the Swiss firm's assets as a boon to its early stage vaccine pipeline, as it attempts to create a simplified cojugated vaccine manufacturing process. GlycoVaxyn comes with an already built-in biological conjugation platform technology.

February 11, 2015 - Bio Space

San Diego startup Cidara Therapeutics, Inc. has completed its $42 million private Series B financing raised from an unnamed group of institutional investors and existing investors, who in the past have included 5AM Ventures, Aisling Capital, Frazier Healthcare and InterWest Partners. Cidara is being closely watched because of its two flagship antifungal programs, Biafungin and Topifungin, both of which aim to treat infections, the former through an IV, weekly administration; the latter via topical application. It has also designed an in-house immunotherapy platform, Cloudbreak, to create antifungals, antibacterials and antivirals.

February 11, 2015 - Bio Space

Hospira, Inc. and Pfenex Inc. have entered into a $342 million agreement to develop and market PF582, Pfenex's "wet" age-related macular degeneration medication similar to Genentech's Lucentis. Pfenex is currently conducting a Phase Ib/IIa clinical trial where 24 patients are receiving monthly eye injections of PF582 for three doses. Those patients will receive ongoing follow-up for 12 months. The clinical trial's primary objective is to evaluate safety and tolerability of PF582, with secondary objectives including comparative pharmacokinetic and pharmacodynamic evaluations to "help demonstrate biosimilarity to Lucentis," the company said in a press release.

February 11, 2015 - Pharmaceutical Business Review

Panacea Pharmaceuticals and Accelovance have entered into a clinical development services agreement to develop and advance Panacea's new nanoparticle-based therapeutic cancer vaccine. Under the deal, Accelovance will support Panacea's clinical development strategies by providing scientific/medical and regulatory expertise. Additionally, Accelovance will also provide contract research organization (CRO) support through project management, clinical monitoring, data management, biostatistics, and safety services for Panacea's clinical trials. Panacea's drug development and clinical advancement will be accelerated as the deal brings together highly complementary capabilities.

February 11, 2015 - Pharmaceutical Business Review

US-based Lion Biotechnologies has secured an exclusive, worldwide license from the National Institute of Health (NIH) to certain patents to develop and commercialize tumor-infiltrating lymphocytes (TIL) therapy to treat metastatic melanoma patients. The exclusive license was received through an amendment to Lion's previously granted, non-exclusive, worldwide license to certain NIH issued and pending patent applications for the use of TIL in metastatic melanoma. Currently, many clinical trials of TIL therapy are being carried out at a number of institutions including the National Cancer Institute and Moffitt Cancer Center.

February 12, 2015 - Bio Space

Canadian drugmaker Valeant Pharmaceuticals International, Inc. has received financing to fund its takeover bid for Salix Pharmaceuticals, Ltd. at more than $150 per share, say people familiar with the deal, Bloomberg reported Thursday. At that bid price, Valeant would be offering Salix a $9.6 billion value, an interesting price point considering that with its net debt, Salix is currently valued at $10.9 billion. That news that pushed shares of Salix up more than 6 percent in afternoon trading on Thursday as investors heralded the news--and added value in the hopes of getting a higher bid. The news comes amid reports that Valeant is once again going shopping, despite pressure from shareholders and Wall Street analysts to rein in its free-spending buying spree. Since 2008, Valeant has acquired more than 100 smaller companies, a pace Chief Financial Officer Howard Schiller told stakeholders earlier this year that will slow, but will still be active.

February 12, 2015 - Healthcare IT News

The Advisory Board Company, a research, technology and consulting firm, has acquired Clinovations, an 80-employee, health IT company, just a half mile away. Financial terms of the deal were not revealed. Clinovations offers strategic, clinical and health IT advisory and management consulting services aimed at helping healthcare organizations derive all the value they can from their IT investments. Clinovations will join the Advisory Board's Southwind division to form Advisory Board Consulting and Management. The Advisory Board acquired Southwind five years ago.

February 12, 2015 - Pharmaceutical Business Review

GlaxoSmithKline has completed the acquisition of remaining shares of Swiss vaccine developer for bacterial infections, GlycoVaxyn, for $190m. Since 2012, GSK owned a minority stake in Glycovaxyn, which has developed a biological conjugation platform technology that could help in the development of new prophylactic and therapeutic vaccines for a range of bacterial diseases. This technology will enable GSK to develop a simplified process to manufacture conjugate vaccines.

February 12, 2015 - Bio Space

Pleasanton, Calif.-based life sciences biotech startup Unchained Labs has received its first round of funding, today announcing it has closed a Series A funding round of $25 million led by Novo Ventures, Canaan Partners and TPG Biotech. Unchained also said Thursday that it had purchased Optim, the world's first and only multiplex protein stability platform for biologics, which it said it will use to measure protein stability parameters as it continues its work on biologics and related therapies. Well know life sciences entrepreneur Tim Harkness is the founder and chief executive officer of Unchained Labs, and venture capitalists involved in the funding said Thursday his past experiences with the other companies was key. Harkness sold ProteinSimple, a Santa Clara, Calif.-based protein analysis startup, for $300 million last year to Techne Corp. 

February 12, 2015 - Fierce Biotech

Lux Capital, a New York venture investor, put together a $350 million fourth fund, cash that will help bankroll startups in energy, technology and biotech. The firm, which also has an outpost in Menlo Park, CA, boasts a life sciences portfolio that includes Cerulean Pharma, Kala Pharmaceuticals, Visterra and Genocea Biosciences. 

February 12, 2015 - Device Space

Genetic testing firm Invitae Corp. bucked an IPO tide that has become choppy of late, raising more than expected in a $102 million offering. The San Francisco company led by Randal Scott boosted the number of shares it offered and priced above its target range. It sold 6.35 million shares at $16. It had been expected to sell 5.35 million shares for between $13 and $15.

February 12, 2015 - Pharmaceutical Business Review

Advaxis and Incyte have entered into a clinical trial collaboration agreement to evaluate the combination of ADXS-HPV and epacadostat to treat early stage cervical cancer. ADXS-HPV is Advaxis's investigational Lm-LLO immunotherapy designed to treat human papillomavirus (HPV)-associated cancers, while epacadostat is Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor. As part of the deal, a multicenter, open-label, preoperative window Phase II trial will be conducted to evaluate the safety and efficacy of ADXS-HPV as a monotherapy and in combination with epacadostat in around 20 patients with Stage I-IIa HPV-associated cervical cancer.

Shire and Valeant are reportedly eyeing $10B bids for Salix

February 13, 2015 - Fierce Biotech

Salix Pharmaceuticals, moving on from an embarrassing inventory scandal, is reportedly headed for a bidding war between two larger companies with diametric approaches to the business of developing drugs. Valeant Pharmaceuticals and Shire have each taken steps toward making a go at the North Carolina company, according reports. Citing unnamed sources, Bloomberg says Valeant has already arranged financing for an offer, which could come in at around $150 a share, a roughly 5% premium to Salix's Wednesday close. Meanwhile, Reuters reports that Shire is a few steps behind on the same trail, working with advisers and ferreting out how to line up funds for a bid.

Insulin Device Maker Valeritas Files for $90 Million IPO

February 13, 2015 - Device Space

Valeritas, which markets a disposable device that delivers basal-bolus insulin therapy for Type 2 diabetes, filed on Thursday with the SEC to raise up to $90 million in an initial public offering. Valeritas' IPO filing arrives just one week after insulin pump maker Asante Solutions postponed its proposed $49 million offering. Another insulin pump company, Tandem Diabetes Care, has traded down about 45% from one year ago and -14% from three months ago.