The White House is relaxing the employer mandate again

February 10, 2014 - The Washington Post

The Treasury Department rolled out Monday afternoon more tweaks to the health care law's requirement that all large employers--those with 50 or more workers--provide insurance coverage to their workers. This is the part of Obamacare was supposed to take effect at the start of 2014, but was delayed by the White House this past summer as the White House was facing significant push back from employers. In today's final rule, the Obama administration is essentially relaxing the employer mandate for 2015--in a big way for medium-sized businesses, and a smaller way for the largest employers. Here's a rundown of the key changes.

February 10, 2014 - Healthcare Finance News

When hospitals merge, the focus tends to be on how much will go to pay off debt and how much will be reinvested in capital improvements. But little notice is paid to a by-product of such transactions - the creation of charitable foundations. A case in point is the joint venture agreement signed last December between LifePoint Hospitals, a hospital company of approximately 60 hospital campuses in 20 states, and Portgage Health in Hancock, Mich., a 36-bed acute care hospital with accompanying skilled nursing unit and other healthcare services.

February 10, 2014 - Pharmaceutical Business Review

Easton Pharmaceuticals, a specialty pharmaceutical company that owns, designs, develops, and markets an array of topically-delivered drugs and therapeutic / cosmetic healthcare products, has finalized and closed on agreement to engage a leading legal consultant on medical marijuana. Subsequent to this agreement, Easton has signed a Letter Of Intent / NDA and has entered into high level negotiations with a private company based out of British Columbia who has been approved for a medical marijuana license to grow and distribute medical marijuana throughout all of Canada. Easton Pharmaceuticals has finalized and closed on an agreement with one of the foremost respected and knowledgeable legal experts and consulting firms in Canada towards medical marijuana.

February 10, 2014 - Bio Space

BioDelivery Sciences International, Inc. announced that it has entered into a definitive securities purchase agreement with a select group of institutional investors led by Federated Kaufmann under which such investors have committed to purchase $60 million of BDSI's common stock in a registered direct offering. Under the terms of the securities purchase agreement, BDSI will sell an aggregate of 7,500,000 shares of its common stock at a price of $8.00 per share. The offering is expected to be consummated on or before February 12, 2014, subject to customary closing conditions. The lead investor is Federated Kaufmann, a family of mutual funds, along with three current institutional holders.

February 10, 2014 - Bio Space

Melinta Therapeutics today announced the closing of a $70 Million Series 3 equity financing. Current investor, Vatera Healthcare Partners, led the round and was joined by existing investors as well as new investors. Proceeds from this financing will be used, in part, to advance delafloxacin, a differentiated fluoroquinolone, through an ongoing Phase 3 study of a single oral dose in individuals with uncomplicated gonorrhea, to the submission of a New Drug Application (NDA) in late 2014.  In addition, the funds will support delafloxacin's two ongoing Phase 3 trials for the treatment of acute bacterial skin and skin structure infections and the selection of lead candidates from Melinta's RX-04 research program. The RX-04 program is focused on the creation of novel molecular structures and selection of unique candidates that target novel binding sites on the bacterial ribosome. Melinta plans to select lead candidates and advance IND-enabling studies in 2014 for the treatment of serious and life-threatening infections caused by multi-drug resistant Gram-negative microbes.

February 10, 2014 - Xconomy

One of the old saws in journalism is to "follow the money" when you're looking for a story. But sometimes you learn even more by following the people. The people, in this case, are biotech venture capitalists. Regular readers of this column know that biotech VC has been going through a historic shakeout the last few years. The institutional investors who back VCs have gotten fed up with the long investment timelines, high degree of risk, and limp returns from this group of well-compensated asset managers. Not surprisingly, many VC firms have been unable to continue to raise new funds, and have turned into zombies.

February 10, 2014 - Bio Space

French drugmaker Sanofi has been one of the weaker players in the industry in terms of new product launches in recent years, but that is set to change, says chief executive Chris Viehbacher. Discussing the company's R&D heritage on Sanofi's fourth-quarter results call, Viehbacher conceded that Sanofi "hasn't brought a lot of new products to market in the last 10 years", with drugs launched since 2009 contributing less than €1bn to its turnover last year. Now, Sanofi has it has "one of the better pipelines in the industry" said Viehbacher, with nine late-stage projects that may potentially be filed over the next 4 years in several disease areas, including diabetes, vaccines, cardiovascular and immunology.

February 10, 2014 - Pharma Times

The rise in volume and value seen for merger and acquisition activity in the pharmaceutical and life sciences sector during fourth-quarter 2013 is set to continue, PricewaterhouseCoopers forecasts. 2013 finished on a high note for deal activity, and the quarter's momentum, driven by macroeconomic stability and growth in key markets, will continue into 2014 as acquirers remain active in the market, the firm predicts in a new analysis.

February 11, 2014 - Reuters

Biotech company Targacept Inc said British drugmaker AstraZeneca would return rights to several pre-clinical compounds, sending the U.S. company's shares down 10 percent in extended trading. A licensing agreement, signed in 2005, continues for the remaining compounds, including AZD1446, a potential treatment for Alzheimer's disease.

February 11, 2014 - Fierce Biotech

The early-year deluge of biotech IPOs is showing no signs of letting up, as another 5 life sciences outfits have chosen this week to test out the market for their shares, looking to haul in as much as $278.2 million in total. First up is NephroGenex, which priced its shares at $12 on Tuesday to raise $37 million in its market debut. The company is developing pyridoxamine dihydrochloride as a treatment for diabetic nephropathy, a progressive kidney disease, and NephroGenex will put $30 million of its bounty to fund a Phase III trial for the drug.

February 11, 2014 - The Wall Street Journal

Global private equity exit volume year to date is at its highest level since 2007, driven in large part by corporations armed with large war chests, according to data provider Dealogic. Through Feb. 12, firms globally announced 80 deals worth a combined $30.4 billion, more than double the $14 billion generated by 109 deals announced during the same 2013 period. The previous high was recorded in 2007, when firms announced $31.4 billion worth of deals selling companies they owned.

February 12, 2014 - Proactive Investors

Mayne Pharma Group is acquiring a number of headache and pain relief brands from Forest Laboratories, Inc for US$10 million and a US$2 million performance-based earn out. The acquisition of ESGIC™, ESGIC PLUS™, LORCET™ and LORCET PLUS™ brands and related assets is expected to be mid-single digit EPS accretive in its first full financial year. The acquisition will be funded through a fully underwritten placement of A$18 million.

February 12, 2014 - Pharmaceutical Business Review

Debiopharm Group and Affinium Pharmaceuticals have announced the acquisition by Debiopharm of Affinium's clinical and preclinical assets as well as its technology platform to identify and develop targeted antibiotics. The clinical assets include AFN-1252, a FabI inhibitor designated by the FDA as a Qualified Infectious Disease Product which has successfully completed a Phase 2a study for the treatment of acute bacterial skin and skin structure infections, and its prodrug AFN-1720, currently in Phase 1 clinical development.

February 12, 2014 - Fierce Pharma

What will Sanofi do with its cash? That's the question now that L'Or�al seems happy to remain the French drugmaker's largest shareholder. Absent the need to hoard cash to buy back L'Or�al shares, at least for now, Sanofi can use that money for something else. Buying back L'Or�al's 9% stake in the company would boost Sanofi's EPS by 6% to 8%, Deutsche Bank's Mark Clark told Reuters. That's why Sanofi shares dropped by 2% on L'Or�al's news. "It doesn't rule anything out in the future, but people will conclude it reduces the chance of Sanofi buying back that 9% stake in due course," Clark said.

February 12, 2014 - Fierce Pharma

Nothing makes analysts happier these days than a prospective spinoff. And with a new chairman stepping in to help conduct the ongoing strategic review of the struggling Reckitt Benckiser pharma unit, some say one could be on the way for the British group. Reckitt Wednesday announced the appointment of new pharma chairman Howard Pien, who will help decide the ailing division's fate, Reuters reports. Eyes have been on the unit, worth an estimated �1.5 billion ($2.5 billion), since October, when CEO Rakesh Kapoor hinted it could end up on the block. Now, however, the new hire has some thinking Reckitt could be pursuing a different strategy

February 12, 2014 - Bio Space

Asclepia Outsourcing Solutions selected as one of the partners to join the European Gram-Negative Antibacterial Engine.  Over 30 European universities, research institutes, and companies, led by GlaxoSmithKline and Uppsala University, are joining forces in a 6-year programme supported by the Innovative Medicines Initiative (IMI) to develop novel antibiotics against Gram-negative pathogens in a project called ENABLE (European Gram-Negative Antibacterial Engine), including open calls for candidates outside the consortium.

February 12, 2014 - Bio Space

MedImmune is looking to UCSF researchers to feed its drug pipeline. In a three-year deal with the University of California, San Francisco's Clinical and Translational Science Institute, the biologics R&D unit of AstraZeneca hopes to spot potential early-research drugs for a wide-range of diseases, including cancer, heart disease, metabolic diseases, neuroscience and infectious diseases. Financial terms of the deal were not disclosed.

February 12, 2014 - Device Space

Miramar Labs�, Inc., a leading medical device manufacturer and maker of the miraDry� System, announced today it has raised $10 million in Series D funding from Aisling Capital, Cross Creek Capital, Domain Associates, Morgenthaler Ventures, and RusnanoMedInvest. The new investment will be used to expand sales activities around the world, support commercialization efforts in Europe given the recent CE Mark approval and support R&D efforts on products for new indications.

February 12, 2014 - Bio Space

Flexion Therapeutics, Inc. announced today the pricing of its initial public offering of 5,000,000 shares of common stock at a price to the public of $13.00 per share. The shares are scheduled to begin trading on the NASDAQ Global Market under the ticker symbol "FLXN" on February 12, 2014. Flexion is offering all of the shares of common stock. Flexion has also granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock. The offering is expected to close on February 18, 2014, subject to customary closing conditions.  BMO Capital Markets and Wells Fargo Securities, LLC are acting as joint book-running managers. Needham & Company and Janney Montgomery Scott are acting as co-managers.

February 12, 2014 - Bio Space

Third Rock Ventures, LLC today announced the formation of Voyager Therapeutics, a gene therapy company developing life-changing treatments for fatal and debilitating diseases of the central nervous system, with a $45 million Series A financing. Voyager's adeno-associated virus approach to gene therapy has the potential to transform treatment for a wide range of CNS diseases with one-time therapies that may dramatically improve patients' lives. The company is committed to advancing the field of AAV gene therapy by innovating and investing in areas such as vector optimization and engineering, dosing techniques, as well as process development and production.  "We believe the time is right for gene therapy, and we have assembled the expertise, technology and strategies to convert the promise of AAV gene therapy into meaningful treatments for patients," said Mark Levin, Interim Chief Executive Officer of Voyager and Partner at Third Rock. "Our world-class founders have driven significant advances in their respective fields, and the combination of their deep clinical and scientific knowledge, our experienced management team and Third Rock's investment positions Voyager to deliver breakthrough therapies to patients suffering from devastating CNS disorders."

February 13, 2014 - Bio Space

Retrophin, Inc. today announced that it has signed an agreement to acquire Manchester Pharmaceuticals� LLC, a privately-held specialty pharmaceutical company that focuses on treatments for rare diseases. Under the terms of the agreement, Retrophin will pay a total of $62.5 million, including an upfront payment of $29.5 million, plus royalties based on product sales. The transaction is expected to close by March 1, 2014. Manchester markets two drugs that have been approved by the U.S. Food and Drug Administration. Chenodal� (chenodeoxycholic acid -- a synthetic bile acid also known as chenodiol) is indicated for patients suffering from gallstones in whom surgery poses an unacceptable health risk due to disease or advanced age. Vecamyl� (mecamylamine HCI tablets) is indicated for the management of moderately severe to severe essential hypertension and uncomplicated cases of malignant hypertension.

February 13, 2014 - Xconomy

What's it worth to add a little deuterium to drugs to boost their abilities? In Wall Street's eyes, about $14 per share. Lexington, MA-based Concert Pharmaceuticals will debut on the Nasdaq today after pricing its IPO at the top of its projected range of $14 per share. The company sold 6 million shares in the deal, up from the 5 million it originally planned to offer, and raised $84 million before discounts due to underwriters. Concert priced at the high end of its projected $12 to $14 per share range. It will trade under the ticker symbol "CNCE."

February 13, 2014 - Pharmaceutical Business Review

Axxess Pharma, a specialty pharmaceutical and nutritional supplements company, has announce the expansion of its TapouT branded product line which now includes Muscle Explosion, a nutritional supplement, in addition to pain relief products both oral and topical, vitamins and minerals already available. The product will be produced by Axxess Pharma's wholly-owned subsidiary, AllStar Health Brands.

February 14, 2014 - Fierce Biotech

Alexion is looking to beef up its pipeline of drugs for ultra-rare diseases. The biotech has struck a deal with little Prothelia and the University of Nevada, Reno, where it will step in and conduct development research on a protein replacement therapy for merosin-deficient congenital muscular dystrophy, or MDC1A. Alexion has an option to buy the company and directly in-license laminin-111 from the university, provided the research pans out.

February 14, 2014 - Device Space

Medtronic Inc. of Fridley has sold off its operations that manufactured and marketed the Pillar Palatal Implant System, a procedure in which thin polyester implants are inserted into a patient's soft palate to lessen the vibrations that result in snoring. Medtronic sold the business in January to the Snoring Center based in Dallas, which has formed Pillar Palatal LLC. Dr. Craig Schwimmer is founder and CEO of the Snoring Center, and David Kaysen, a Minnesota resident, is president and CEO of Pillar Palatal. Terms of the sale were not disclosed.

February 14, 2014 - Device Space

PhotoMedex, Inc. and LCA-Vision, Inc. today announced the signing of a definitive agreement pursuant to which PhotoMedex will acquire LCA-Vision for $5.37 per share in cash, or approximately $106.4 million. PhotoMedex is a global skin health company providing integrated disease management and aesthetic solutions to dermatologists, professional aestheticians and consumers. LCA-Vision Inc. is a leading provider of laser vision correction services under the LasikPlus brand. This proposed transaction is subject to customary closing conditions, including LCA-Vision shareholder approval and regulatory approvals, and is subject to a 30-day "go shop" period. The Boards of Directors of both PhotoMedex and LCA-Vision have voted unanimously in favor of the transaction, which is expected to close in the second quarter of 2014. LCA-Vision's operations are expected to be accretive to PhotoMedex's cash EPS in 2014, excluding one-time, transaction-related items.

February 14, 2014 - Device Space

Inogen, Inc. today announced the pricing of its initial public offering of 4,411,763 shares of its common stock at a price to the public of $16.00 per share. Inogen is offering 3,529,411 shares of common stock and certain selling stockholders are offering 882,352 shares of common stock. In addition, certain selling stockholders have granted the underwriters a 30-day option to purchase up to 661,764 additional shares of common stock at the initial public offering price. The shares are expected to begin trading on The NASDAQ Global Select Market on February 14, 2014, under the symbol "INGN".  J.P. Morgan is acting as sole book-running manager for the offering, Leerink Partners is acting as lead manager, and William Blair and Stifel are acting as co-managers.

February 14, 2014 - Device Space

Lumenis Ltd. today announced that it has commenced an initial public offering of 6,250,000 ordinary B shares pursuant to a registration statement filed with the U.S. Securities and Exchange Commission. The underwriters will be granted a 30-day option to purchase up to 937,500 additional ordinary B shares from the selling shareholders. The initial public offering price is currently expected to be between $15.00 and $17.00 per ordinary B share. The ordinary B shares are expected to trade on the Nasdaq Global Market.  Goldman, Sachs & Co., Credit Suisse Securities LLC and Jefferies LLC will serve as joint book-running managers for the proposed offering. Wells Fargo Securities, LLC will serve as co-manager.

February 14, 2014 - Pharmaceutical Business Review

French pharmaceutical firm Pierre Fabre and Indian biotech company Aurigene have entered into a collaborative license, development and commercialization agreement granting Pierre Fabre global worldwide rights (excluding India) to a new immune checkpoint modulator, AUNP-12. Compared to other molecules currently in development in the immune therapy cancer space, AUNP-12 provides a breakthrough mechanism of action in the PD-1 pathway.

February 14, 2014 - Bio Space

AVEO Oncology and Astellas Pharma Inc. today announced the companies will end their worldwide collaboration and license agreement for the development and commercialization of investigational agent tivozanib. Tivozanib is an investigational tyrosine kinase inhibitor of all three vascular endothelial growth factor receptors. Astellas has exercised its right to terminate the agreement signed in 2011 for strategic reasons, based on the clinical status of the three indications studied. Additionally, the companies agreed to discontinue the ongoing Phase 2 BATON (Biomarker Assessment of Tivozanib in ONcology) study in patients with colorectal cancer. The termination of the collaboration will be effective August 11, 2014 at which time tivozanib rights will be returned to AVEO. In accordance with the collaboration and license agreement, committed development expenses will be shared equally.

February 14, 2014 - Pharmaceutical Business Review

Russia-based Infectex has entered into an exclusive license agreement with South Korean biotech firm Qurient for its tuberculosis-fighting drug Q203. Q203 is being developed for multidrug-resistant and extensively drug-resistant tuberculosis and is the first drug in its class with an original mechanism of action. Under the deal, Infectex will develop and commercialize Q203 in Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, Uzbekistan and Ukraine.

February 13, 2014 - Healthcare IT News

Optum Labs, the research center founded by UnitedHealth and Mayo Clinic, has added seven new health organizations, which will join in on data mining research to find innovative ways to improve quality and reduce costs.