Merck Acquires IOmet Pharma

Merck announced that it has acquired IOmet, a privately-held UK-based drug discovery company focused on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism. Under terms of the agreement, Merck, through a subsidiary, will acquire IOmet, including its comprehensive pre-clinical pipeline of IDO (indoleamine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase), and dual-acting IDO/TDO inhibitors. Based on the transaction, IOmet will become a wholly owned subsidiary of Merck. 

IDO1 and TDO, the rate-limiting enzymes in the pathway that metabolizes the essential amino acid tryptophan, have emerged as key targets for the pharmaceutical industry in the cancer immunotherapy field. Overexpression of these enzymes has been detected in a variety of cancers – including glioma, melanoma, lung, ovarian, and colorectal cancers – and is associated with poor prognosis and survival. IDO1 and TDO overexpression leads to tryptophan depletion and high tumor levels of the breakdown product, kynurenine. This elevated kynurenine/tryptophan (K/T) ratio suppresses the body’s immune response to cancer, thus facilitating tumor progression and metastasis. Extensive preclinical evidence, and emerging clinical data, suggests that inhibition of IDO1 and/or TDO may synergize with, and help overcome resistance to, existing clinical cancer therapies, in particular other immunotherapy-based treatments. 

Zydus expands animal health business with a strategic acquisition

 Zydus Group which is a leading player in animal health business through its division Zydus Animal Health has announced the strategic acquisition of select brands and the manufacturing operations in Haridwar, India of Zoetis a global animal health company. The acquisition will helps Zydus expand its animal health business in India and gain access to manufacturing operations which have also been catering to global markets.

As a result of this acquisition, Zydus gains access to a wide range of nutrition as well as therapeutic products which have strong brand equity and a combined turnover of Rs 171 Crore. A major boost to Zydus' portfolio would be the addition of livestock farmcare products which are well accepted in the market. Zydus' access to the WHO GMP approved manufacturing facility is expected to boost its exports and institutional business. The plant spread over 10,000 sq. metres manufactures Tablets, Liquid Orals and Injectables.

EISAI COMPLETES ACQUISITION OF LIAONING TIANYI BIOLOGICAL PHARMACEUTICALS

Eisai Co Ltd announced that regarding the acquisition of Chinese generic pharmaceutical company Liaoning TianYi Biological Pharmaceutical Co., Ltd. previously announced on November 27, 2015, the conditions of transfer have been arranged, including receiving a new business license from the regulatory authority in China, and the acquisition has been completed.

The trading name of Liaoning TianYi Biological Pharmaceutical Co., Ltd. was changed to “Eisai (Liaoning) Pharmaceutical Co., Ltd.”, and the company has become a wholly-owned subsidiary of Eisai China Holdings Ltd.

Through this acquisition, Eisai has entered the generic pharmaceutical business in China in addition to expanding its existing business focused on new medicines. By further strengthening its business foundation established over 25 years of doing business in China and providing a stable supply of high quality generic pharmaceuticals, Eisai is able to fulfill an even wider range of medical needs in China. Eisai will continue to further contribute to increasing the benefits for a greater number of patients and their families throughout China.

GSK completes divestment rights of ofatumumab to Novartis

GlaxoSmithKline Plc announced the completion of its transaction to divest its rights to ofatumumab for auto-immune indications to Novartis Pharma AG (“Novartis Pharma”), a subsidiary of Novartis AG, following regulatory approval.

The consideration payable by Novartis Pharma to GSK may reach up to $1,034 million and comprises a series of milestone payments as: $300 million paid at closing; $200 million payable subject to the start of a phase III study in relapsing remitting multiple sclerosis by Novartis; further contingent payments of up to $534 million payable on the achievement of certain other development milestones.

Novartis Pharma will also pay royalties of up to 12 per cent to GSK on any future net sales of ofatumumab in auto-immune indications. Income generated from the divestment will be treated as non-core in line with the accounting policies outlined in the third quarter financial results announcement of 28 October 2015.

 

GSK acquires BMS's R&D HIV assets

GlaxoSmithKline plc announced that its global HIV business, ViiV Healthcare, has reached two separate agreements with Bristol-Myers Squibb, to acquire its late-stage HIV R&D assets; and to acquire Bristol-Myers Squibb’s portfolio of preclinical and discovery stage HIV research assets.

These potential therapies have novel modes of action and would offer significant new treatment options to patients with HIV. In addition to being developed as standalone treatment options, these new assets complement ViiV Healthcare’s existing portfolio and therefore offer multiple opportunities for development as combination therapies.

The late-stage asset purchase comprises an upfront payment of $317 million, followed by development and first commercial sale milestones of up to $518M, and tiered royalties on sales. The purchase of preclinical and discovery stage research assets comprises an upfront payment of $33 million, followed by development and first commercial sales milestones of up to $587M, and further consideration contingent on future sales performance.
 

STADA signs contract to purchase Vannier

STADA Arzneimittel AG and STADA subsidiary BEPHA Beteiligungsgesellschaft für Pharmawerte mbH signed a contract to purchase the Argentinian generics producer Laboratorio Vannier S.A.

The purchase price, which includes a small performance-related component, amounts to a maximum of US dollar 13.0 million in cash. The seller is a private individual. Vannier, whose headquarters is in Buenos Aires, was founded in 1992 and in financial year September 2014 to August 2015 achieved sales of 72.0 million Argentinean pesos (approximately Euro 7.0 million), which represents growth of 43 percent from the previous year in the local Argentinean currency. The company’s production is certified in accordance with the local GMP standard and it currently has 88 employees. Vannier’s sales activities are focused on niches which are subject to few price regulations, particularly on conditions of the central nervous system (CNS) , cardiology and diabetes.

The acquisition is expected to be concluded at the beginning of January 2016. The consolidation of sales is envisaged from January 1, 2016. Payment of the purchase price will be made at the time of completion of the acquisition. For the financing, STADA will use cash on hand and existing free credit lines. It is expected that the acquisition will contribute to net income from the time of consolidation.

Biosense Webster Inc Acquisition of Coherex Medical Inc

Biosense Webster, Inc. announced that it has acquired Coherex Medical, Inc. a privately held medical device company based in Salt Lake City, Utah focused on the development of the Coherex WaveCrest^® Left Atrial Appendage (LAA) Occlusion System. The device is designed to permanently occlude the LAA in high-risk atrial fibrillation (Afib) patients to help reduce the incidence of stroke caused by the migration of blood clots formed in the LAA, which is recognized as the source of blood clots in approximately 90 percent of patients who have Afib.

Afib is associated with a five-fold increased risk of stroke and prevention in patients with Afib represents a large unmet clinical need. This acquisition reinforces the company's commitment to providing innovative, minimally invasive therapies for the treatment of Afib, which affects over 3 million patients in the United States and 20 million worldwide.

The Coherex WaveCrest^® LAA occlusion system received CE Mark in September 2013. It is not available for investigational use or commercial distribution in the U.S. at this time.

Merck Animal Health to Acquire Harrisvaccines

Merck Animal Health and Harrisvaccines, Inc., announced the companies have entered into an agreement under which Merck Animal Health will acquire Harrisvaccines, a privately-held company that develops, manufactures and sells vaccines for food production and companion animals.

Harrisvaccines offers innovative technology and an important portfolio of vaccines, with a focus on production animals, an increasingly important segment as consumer demand for protein continues to grow worldwide. The company has a unique RNA Particle technology which represents a breakthrough in vaccine development.  It also has a highly versatile production platform able to target a wide range of viruses and bacteria. Pathogens are collected from a farm and specific genes are sequenced and inserted into RNA particles, making safe, potent vaccines able to provide herd-specific protection.

Johnson and Johnson will aquire Novira Therapeutics

Johnson & Johnson announced a definitive agreement to acquire Novira Therapeutics, Inc., a privately held, clinical-stage biopharmaceutical company developing novel therapies for curative treatment of chronic hepatitis B virus (HBV) infection.  The acquisition includes Novira’s portfolio of novel antivirals, including its lead candidate, NVR 3-778.  Financial terms of the transaction have not been disclosed.

NVR 3-778 is a small molecule, direct acting antiviral, for oral administration in patients with HBV that inhibits the HBV core or capsid protein. HBV core is a novel and promising drug target since it is involved in multiple activities required for viral replication and persistence.

The closing is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The transaction is expected to close during the fourth quarter of 2015.

Shire Plc to Acquire Dyax Corp

Shire plc and Dyax Corp announced that Shire will acquire Dyax for $37.30 in cash per Dyax share, for aggregate upfront consideration of approximately $5.9 billion. Dyax shareholders may receive additional value through a non-tradable contingent value right (CVR) that will pay $4.00 in cash per Dyax share upon approval of DX-2930 in HAE, representing a potential additional $646 million in aggregate contingent consideration.

Dyax is a publicly traded, Massachusetts-based biotechnology company primarily focused on the development of plasma kallikrein (pKal) inhibitors for the treatment of HAE, a debilitating and sometimes life-threatening rare genetic disease. Dyax has already successfully developed and commercialized KALBITOR, which is approved for HAE acute treatment in patients 12 years of age and older, and represented an early innovation in HAE treatment.

Dyax’s most advanced clinical program is DX-2930, a Phase 3-ready, fully humanized monoclonal antibody targeting pKal with proof-of-concept Phase 1B efficacy data. This data demonstrate a > 90% reduction in HAE attacks compared to placebo in the 300mg/400mg arms in patients with > 2 attacks in the 3 months prior to study entry.

Mylan Receives U.S. FTC Clearance

Mylan N.V. announced the U.S. Federal Trade Commission ("FTC") has cleared the company's proposed transaction to acquire Perrigo Company plc subject to Mylan's divestiture of certain products following the consummation of the offer. The FTC clearance represents the final regulatory clearance needed by Mylan to close its acquisition of Perrigo and represents the last remaining condition that needs to be satisfied for the successful completion of the offer other than the acceptance condition. 

Under the terms of Mylan's offer, Perrigo shareholders will receive $75 in cash and 2.3 Mylan ordinary shares for each Perrigo ordinary share. On September 14, 2015 Mylan officially commenced its formal offer to acquire all outstanding ordinary shares of Perrigo. 

The offer is being made in accordance with Mylan's announcement (dated April 24, 2015 and amended on April 29, 2015 and on August 13, 2015) pursuant to Rule 2.5 of Irish Takeover Rules that set forth Mylan's legally binding commitment to commence an offer and the Offer to Exchange / Prospectus (being the offer document for the purposes of the Irish Takeover Rules) dated September 14, 2015.  The offer and withdrawal rights are scheduled to expire at 1:00 P.M. (Irish time)/8:00 A.M. (New York City time) on November 13, 2015, unless the offer is extended with the consent of the Irish Takeover Panel.  The acceptance condition for the offer requires greater than 50% of Perrigo ordinary shares to have been tendered into the offer.

Bristol-Myers Squibb to Acquire Cardioxyl Pharmaceuticals, Inc

BMS announced that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the issued and outstanding capital stock of Cardioxyl, a private biotechnology company focused on the discovery and development of novel therapeutic agents for the treatment of cardiovascular disease. The acquisition will give Bristol-Myers Squibb full rights to Cardioxyl’s lead asset CXL-1427, a novel nitroxyl (HNO) donor (prodrug) in Phase 2 clinical development as an intravenous treatment for acute decompensated heart failure (ADHF). The transaction includes upfront and near-term milestone payments of up to $300 million and potential additional consideration of up to $1.775 billion upon the achievement of certain development, regulatory and sales milestones. The transaction, which is expected to be dilutive to 2015 GAAP EPS by approximately $0.12, with minimal dilution to non-GAAP EPS in both 2015 and 2016, has been approved by the boards of directors of both companies. 

CXL-1427 releases nitroxyl, a molecule that has demonstrated beneficial effects on heart muscle and vascular function. Pre-clinical and early clinical data indicate that CXL-1427 improves how the heart muscle contracts and relaxes without increasing heart rate or the demand for oxygen. Current therapies for ADHF that improve heart muscle function produce an increase in heart rate and/or oxygen consumption, and are associated with an increased risk for ischemia, arrhythmias and increased mortality. 

Pfizer Completes Acquisition Of Nimenrix And Mencevax

Pfizer Inc. announced that it has completed the acquisition of GlaxoSmithKline’s quadrivalent meningococcal ACWY vaccines Nimenrix and Mencevax. 

 

Nimenrix (meningococcal serogroups A, C, W-135 and Y conjugate vaccine) is a single-dose meningococcal ACWY-TT (tetanus toxoid) conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. It is indicated for all age groups above one year of age. Launched three years ago, Nimenrix is currently registered and approved for sale in 63 countries across the European Economic Area (EEA 30), Canada, Australia and Emerging Markets, with registrations under review in another 17 countries across Africa, Asia, Eastern Europe and the Middle East.

Mencevax (meningococcal polysaccharide serogroups A, C, Y and W-135 vaccine) is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers in countries where the disease is endemic or highly epidemic. Mencevax is indicated for use across all age groups from 2 years of age, and is currently registered and approved in 78 countries across Africa, Asia, Australia, Europe, Latin America, Middle East and New Zealand.

Merger Project of companies of Grifols and Arrahona Optimus

With the aim of reducing management costs, the boards of directors of Grifols, S.A. and Arrahona Optimus, S.L. approved on 29 May 2015 a Merger Project, whereby in compliance with article 51 of Law 3/2009 of 3 April 2009 on structural modifications of commercial companies (Ley de Modificaciones Estructurales de las Sociedades Mercantiles), both management bodies approve to propose that Grifols, S.A. absorbs its wholly owned subsidiary Arrahona Optimus, S.L

AstraZeneca purchases US biologics manufacturing facility

AstraZeneca added to its biologics manufacturing capability in the US with the purchase of a high-tech biologics bulk manufacturing facility from Amgen Inc. Over time, the LakeCentre facility, located in Boulder, Colorado will increase manufacturing and production capacity to support the company’s extensive portfolio of biologics medicines.

AstraZeneca plans to start staffing the facility immediately to support refurbishment and infrastructure improvements. Once complete, the site is expected to be operational and licensed for commercial production by late 2017, providing for additional capacity within the company’s biologics operations.

In the longer- term, this site could create up to 400 highly skilled jobs, subject to relevant approvals by the local authorities. The facility will eventually double the biologics manufacturing capacity in the US to meet the needs of the maturing AstraZeneca pipeline. Currently biologics make up 50 percent of the company’s pipeline with more than 120 ongoing programmes, including over 30 in clinical development.

Aspen Seeks Drugs Acquisitions

Aspen Pharmacare Holdings Ltd., Africa’s largest generic-drugs maker, is looking for acquisitions and seeking to expand its infant nutrition business after international sales boosted full-year profit.

The Durban, South Africa-based company, which supplies medicines in more than 150 countries, is seeking purchases in China, Japan and Southeast Asia, Deputy Chief Executive Officer Gus Attridge said by phone on Wednesday. While Aspen “won’t walk away from any great opportunity,” the company is seeking to expand its infant-milk, anti-coagulant and women’s-health units, he said.

The company has spent more than $2 billion on acquisitions from drugmakers including GlaxoSmithKline Plc and Merck & Co. in the past three years to boost its portfolio of medicines and manufacturing sites. London-based Glaxo took a stake in the company’s Japanese unit in October to boost operations in that country.

Net income climbed 3.9 percent to 5.2 billion rand ($380 million) in the year through June, Aspen said in an earlier statement. That compares with a 5.16 billion-rand estimate of six analysts surveyed by Bloomberg. Sales increased 22 percent to 36.1 billion rand, boosted by a 46 percent gain in international revenue.

Profit margins at the South African unit were pressured by ongoing weakening of the rand relative to the U.S. dollar as well as high wage and energy-cost inflation.  Increased sales of low-margin antiretroviral drugs to South Africa’s government also suppressed margins, Attridge said.

In May, the company agreed to sell a drugs business to Dublin-based Endo International Plc for about $130 million and two pharmaceutical portfolios to units of Strides Arcolab Ltd. of India for $301 million. The majority of the proceeds have been earmarked for acquisitions.

Sun Life Financial Inc to Buy Assurant Unit

Sun Life Financial Inc., Canada’s third-largest life insurer, agreed to buy an employee-benefits business from Assurant Inc. to expand in the U.S. Assurant will receive $940 million in the sale, the New York-based company said in a statement Wednesday. Sun Life said in a separate statement that its net investment will be $975 million including capital required to support the operation.

Sun Life Chief Executive Officer Dean Connor is expanding beyond Canada as Assurant turns its focus to property-casualty coverage, including policies that protect consumer electronics and homes. Sun Life purchased Redmond, Washington-based asset manager Prime Advisors this year.

Sun Life expects the deal to add 8 Canadian cents a share to 2016 earnings, rising to 17 cents a share by 2019, according to the statement, excluding transaction and integration costs. The transaction may be completed by the end of next year’s first quarter, Sun Life said. The 1,700 employees at the Assurant unit will be offered positions with Toronto-based Sun Life, Assurant said in a statement.

The acquisition is the largest in more than a decade for Sun Life, which bought rival Clarica Life Insurance Co. in 2002 and two U.S.-based Liberty Financial units in 2001. Gaining Assurant’s assets increases Sun Life’s U.S group-benefits unit by 50 percent to about $4 billion in premiums.

Allergan agrees to acquire AqueSys

Allergan PLC said late Thursday it agreed to acquire privately-held AqueSys Inc. for $300 million cash. AqueSys makes medical devices that are placed in the eye to reduce pressure associated with glaucoma. Allergan said that it will also pay milestone payments for regulatory approval and commercialization of AqueSys's XEN45 device, which is expected to get U.S. approval in late 2016 or early 2017. Allergan plans to close the acquisition in the fourth quarter.

SUN PHARMA COMPLETED Opiates Business Acquisition

Sun Pharmaceutical Industries Ltd begins the integration of its Opiates business in Australia following the successful completion of this acquisition from GKS. This acquisition fortifies Sun Pharma's global position with two Opiates manufacturing facilities in Port Fairy and Latrobe complementing its current API manufacturing footprint globally.

Sun Pharma now offers a rich basket of Opiates product line in addition to a large API portfolio and dosage formulations covering a broad range chronic and acute prescription drugs. The acquisition also brings a specialized team to drive business growth.

The Opiates acquisition allow Sun Pharma to:

• Significantly expands its narcotic raw material market share
• Enhance Opiate Alkaloids portfolio and depth in Global opiates market
• Strengthen its strategic position in the global opiates business

Valeant Pharmaceuticals To Acquire Synergetics USA

Valeant Pharmaceuticals International, Inc announced that its affiliate has entered into a definitive agreement under which Valeant will acquire Synergetics USA, Inc for $6.50 per share in cash. In addition to the upfront cash payment, Synergetics stockholders will receive additional cash payments of up to $1.00 per share if specified sales milestones are achieved following the closing.  The transaction is expected to close in the fourth quarter of 2015 and is subject to customary closing conditions and regulatory approvals. 

Under the terms of the agreement, Valeant will promptly commence a tender offer to acquire all outstanding shares of Synergetics' common stock for $6.50 per share in cash plus one contingent value right entitling the stockholder to receive up to $1.00 per share if specified sales thresholds for Synergetics are achieved following the closing.  The details of the contingent cash consideration payments are as follows:

• $0.50 per share in cash payable upon sales of the Company's ophthalmology products achieving $55 million on a trailing four calendar quarter basis prior to June 30, 2018; and
• $0.50 per share in cash payable upon sales of the Company's ophthalmology products achieving $65 million on a trailing four calendar quarter basis prior to June 30, 2018, with a pro-rata portion payable for net sales above $55 million but less than $65 million.

Following the successful completion of the tender offer, Valeant will acquire all remaining shares not tendered in the tender offer through a second-step merger at the same price and with the obligation to make the same contingent cash consideration payments as are made to stockholders tendering their shares in the tender offer. The tender offer and withdrawal rights are expected to expire at 12:00 midnight, New York City time on the 20th business day after the launch of the tender offer, unless extended in accordance with the merger agreement and the applicable rules and regulations of the U.S. Securities and Exchange Commission.

The consummation of the tender offer is subject to various conditions, including a minimum tender of a majority of outstanding Synergetics' shares on a fully-diluted basis, the expiration or termination of any applicable waiting periods under applicable competition laws, and other customary conditions. The Board of Directors of Synergetics unanimously approved the transaction.