Sensata Acquires Wabash; pSivida Reports FDA Labeling Discussions for ILUVIEN® for DME Print
By Staff and Wire Reports   
Wednesday, 18 December 2013 20:50
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 18, 2013.

Sensata Technologies Holding N.V. (NYSE: ST) announced certain subsidiaries have reached an agreement to acquire Wabash Technologies, Inc. from an affiliate of Sun Capital Partners, Inc.  Terms of the acquisition were not disclosed.  The transaction is not subject to regulatory review and is expected to close in January.

Wabash is a leading designer and manufacturer of a broad range of custom-designed sensors, including rotary and linear position, speed and engine timing sensors.  The company also supplies fuel injection stators/actuators for diesel engines.

Wabash was founded in 1946 and employs approximately 960 people, is headquartered in Troy, Michigan and operates manufacturing facilities in Mexicali, Mexico and Huntington, Indiana.  The company's customer base includes major U.S. and European OEMs and leading Tier 1 systems suppliers serving the automotive, heavy vehicle, agriculture, construction and off-highway markets. Wabash is expected to generate revenues of approximately $75 million in 2013.

"This transaction aligns with Sensata's previously announced objective to execute on acquisitions that are close to our core business.  Acquisitions such as this will help us achieve our target operating model of double-digit revenue growth during times of core market headwinds," said Martha Sullivan, Sensata Technologies President and Chief Executive Officer.  "Wabash's position in the magnetic, speed and position sensing market builds on current Sensata capabilities and provides new capabilities in throttle position and transmission range sensing while enabling additional entry points into the important heavy vehicle and off-road market."

Sensata's Chief Operating Officer and Acting Chief Financial Officer Jeff Cote said, "The transaction will be accretive to earnings in 2014 prior to integration costs, and although slightly dilutive after integration costs, we believe it represents a strategically sound use of capital."


 pSivida Corp. (NASDAQ: PSDV) (ASX: PVA)
, a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that its licensee Alimera Sciences has entered into labeling discussions with the U.S. FDA for ILUVIEN® for Diabetic Macular Edema (DME) and, as a result, reported its agreement with the FDA that the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting to discuss ILUVIEN for DME was no longer necessary.

Alimera reported that it plans to respond to the FDA's October 2013 Complete Response Letter (CRL) in the first quarter of 2014 and intends to address the concerns raised regarding the facility at which ILUVIEN for DME is manufactured and to provide recent safety data from patients in the United Kingdom and Germany. Alimera reported that the FDA has indicated that new clinical trials will not be required in connection with the FDA's review of ILUVIEN for DME prior to approval.

“We are very pleased with Alimera's discussion with the FDA with respect to appropriate labeling for ILUVIEN for DME and next steps required to move it closer to an FDA approval,” said Paul Ashton, Ph.D., President and CEO of pSivida. “We look forward to a first quarter resubmission and, hopefully, approval of this product. If approved, we will be entitled to a $25 million milestone payment from Alimera and 20% of net profits (as defined) on sales of ILUVIEN for DME by Alimera in the U.S.”

Also Wednesday:

Alcobra Ltd. (Nasdaq:ADHD)
, an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate, MG01CI (Sustained-Release Metadoxine), to treat cognitive dysfunction, announced today that the U.S. Food & Drug Administration has granted "Orphan Drug" designation to Metadoxine in the treatment of Fragile X Syndrome.

Alimera Sciences, Inc. (NASDAQ: ALIM)
, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has entered into labeling discussions with the U.S. Food and Drug Administration (FDA) for ILUVIEN® and, as a result, reached an agreement with the FDA that Alimera's participation in the January 2014 Dermatologic and Ophthalmic Advisory Committee meeting was no longer necessary.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, is scheduled to present at the 32nd Annual J.P. Morgan Conference at the Westin St. Francis Hotel in San Francisco, Calif.

Chimerix, Inc. (Nasdaq:CMRX)
, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the appointment of Linda M. Richardson as Chief Commercial Officer.

Cleveland BioLabs, Inc. (Nasdaq:CBLI)
today reported that Chief Development Officer, Jean Viallet, MD will leave the Company to assume an oncology global clinical research leadership role at Bristol-Myers Squibb, effective January 3, 2014.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT)
, a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, will ring the Opening Bell at the NASDAQ MarketSite in New York today in honor of Conatus' successful initial public offering (IPO) in July 2013 and subsequent advancement of its lead development program.

The Cooper Companies, Inc. (NYSE:COO)
will present at the 32nd Annual J.P. Morgan Healthcare Conference in San Francisco, Calif., on January 14, 2014.

Dehaier Medical Systems Ltd. (Nasdaq:DHRM)
, an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, announced today that it has successfully bid on a large-scale medical equipment procurement valued at approximately $600,000 (RMB 3.7 million).

EHouse Global, Inc. (OTCBB:EHOS)
, an emerging specialty nutraceutical company in the $26 Billion dietary supplement industry, would like to announce the launch of their new product line of 16 different nutritional supplements, under the brand, which are all gluten free, and natural.

Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-functional lipid ingredients, announced today that it signed a term sheet on December 16, 2013 with Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) ("Neptune") and Acasti Pharma Inc. ("Acasti") memorializing the terms of a settlement among the parties.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
announced today that the U.S. Patent and Trademark Office has issued U.S. Patent No. 8,609,896.

Neptune Technologies & Bioressources Inc. (Nasdaq:NEPT) (TSX:NTB)
and Acasti Pharma Inc.  (Nasdaq:ACST) (TSX-V:APO), a Neptune subsidiary, announce that on December 16, 2013, the Administrative Law Judge presiding over the pending International Trade Commission (ITC) Investigation involving Neptune and Acasti; and Enzymotec Ltd., and Enzymotec USA, Inc. (collectively, "Enzymotec") granted the parties' joint motion to stay the proceedings for thirty days.  

Taiwan Liposome Company Limited (TLC) (4152.TWO)
announced today the signature of their collaboration agreement with Sandoz AG, an affiliate within the generics division of Novartis (NYSE:NVS).

Hospital participation in accountable care organizations (ACOs) is projected to double in 2014, according to Premier, Inc.'s (Nasdaq:PINC) fall 2013 Economic Outlook C-suite survey.

Orgenesis, Inc. (OTCQB: ORGS)
, a development-stage company with a novel regenerative medicine technology that converts a diabetes patient's liver cells into functioning insulin-producing cells, has entered into a $3 million common stock purchase agreement with Kodiak Capital Group LLC, a Newport Beach, Calif.-based institutional investor.

Response Genetics, Inc. (Nasdaq:RGDX)
, a company focused on the development and sale of molecular diagnostic tests that help determine a patient's response to cancer therapy, today announced that it has signed agreements with two new Blue Cross Blue Shield health plans.

XOMA Corporation (Nasdaq:XOMA)
announced today the closing of the offering of 10,925,000 shares of its common stock, including 1,425,000 shares of common stock that were issued upon the exercise in full of the underwriters' option to purchase additional shares, at a price to the public of $5.25 per share.

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