Merck Enhances Immuno-Oncology Portfolio with Acquisition of cCAM Biotherapeutics

merckKENILWORTH, N.J. & MISGAV, Israel–(BUSINESS WIRE)–Merck (NYSE:MRK), known as MSD outside the United States and Canada, and cCAM Biotherapeutics announced today that the companies have signed a definitive agreement under which Merck will acquire cCAM Biotherapeutics, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies.

Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95 million in cash. In addition, cCAM shareholders of record are eligible to receive a total of up to $510 million associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction is subject to certain closing conditions.

“We continue to strengthen our portfolio of immunotherapeutic candidates through strategic collaborations and acquisitions,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “The acquisition of cCAM supports our objective to advance the care of patients with cancer by stimulating tumor-directed immune responses.”

The acquisition provides Merck with several early immunotherapy candidates including cCAM Biotherapeutics’ lead pipeline candidate, CM-24 – a novel monoclonal antibody (mAb) targeting the immune checkpoint protein CEACAM1 that is currently being evaluated in a Phase 1 study for the treatment of advanced or recurrent malignancies, including melanoma, non-small-cell lung, bladder, gastric, colorectal, and ovarian cancers. Based on the transaction, cCAM Biotherapeutics, domiciled in Israel, will become a wholly owned subsidiary of Merck and continue to advance the development of CM-24 in its ongoing Phase 1 clinical trial. cCam was originally established under the Israeli Office of Chief Scientist’s incubators program.

“Merck’s excellence and leadership in immuno-oncology provides a strong foundation for advancing CM-24, for the treatment of people with cancer,” said Pini Orbach, Ph.D., Chairman of the Board, cCAM Biotherapeutics and Head of Pharma at Arkin Holdings. “This is a significant achievement for cCAM Biotherapeutics, as well as a vote of confidence in the Israeli innovative biotech industry as a whole.”

About CEACAM1 and CM-24

CM-24 is a humanized monoclonal antibody directed against CEACAM1, an immune checkpoint protein belonging to the Human CEA (Carcino-Embryonic Antigen) protein family. Evidence has shown that CEACAM1 is expressed on tumor lymphocytes, and is up-regulated in several cancer types. Preclinical studies have shown evidence that CM-24 enhances the cytotoxic activity of tumor-infiltrating lymphocytes (TILs) against various CEACAM1-positive tumor cell lines. CM-24 is being developed for multiple oncological indications according to the expression pattern of its target protein.

About cCAM Biotherapeutics

Founded in 2010 and led by Tehila Ben-Moshe, Ph.D., cCAM is a biopharmaceutical company focused on the discovery and development of novel immunotherapies to treat cancer. Its lead product, CM-24, is a first-in-class humanized anti-CEACAM1 monoclonal antibody undergoing Phase 1 clinical trials. CM-24 is based on the research of Professor Gal Markel, Head of Research, Ella Institute of Melanoma, at Sheba Academic Medical Center Hospital, Israel. Main and equal Investors in the Company include: Arkin Holdings, OrbiMed and Pontifax. For more information, please visithttp://ccam-bio.com/.

Merck’s Focus on Cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck Oncology, helping people fight cancer is our passion and supporting accessibility to our cancer medicines is our commitment. Our focus is on pursuing research in immuno-oncology and we are accelerating every step in the journey – from lab to clinic – to potentially bring new hope to people with cancer. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.

About Merck & Co., Inc., Kenilworth, N.J., USA

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Shire to Acquire NPS Pharma as Further Step in Building a Leading Biotech

Dublin-based Shire has agreed to use its AbbVie breakup fee to acquire rare disease drugmaker NPS Pharmaceuticals, Inc.

The companies announced that they have entered into a merger agreement, under which Shire will acquire all the outstanding shares of NPS Pharma for $46 per share in cash, for a total consideration of approximately $5.2 billion. The deal strengthens Shires business in rare diseases.

Shire was first linked to NPS last May, however in July, Shire agreed to be acquired by US-based AbbVie, in a deal worth $55 billion. Last fall, the deal fell through after the Treasury Department announced new rules targeting companies trying to strike inversions deals, allowing US companies to reincorporate their businesses overseas. Since AbbVie decided to break the deal, it was required to pay Shire $1.6 billion in cash.

Shire’s acquisition of NPS will provide the company with two new drugs: Gattex, a treatment for short-bowel syndrome (SBS), and Natpara, a drug awaiting FDA-approval for treatment of hypoparathyroidism. The FDA is expected to make a decision on whether to approve Natpara by January 24.

“The acquisition of NPS Pharma is a significant step in advancing Shire’s strategy to become a leading biotechnology company. With our global strength and expertise in both rare diseases and GI, Shire is uniquely positioned to drive the continued success of Gattex/Revestive, and, if approved, commercialize NPS Pharma’s pipeline compound Natpara/Natpar,” said Shire’s Chief Executive Officer, Flemming Ornskov, MD, MPH.

Francois Nadar, MD, President, Chief Executive Officer and Director of NPS Pharma, said, “We look forward to accelerating the growth of the NPS Pharma portfolio based on our proven track record of maximizing value from acquired assets and commercial execution. The NPS Pharma organization will be a welcome addition to Shire will be a welcome addition to Shire as we continue to help transform the lives of patients with rare diseases.”

Source: Shire

PBM Sees New Cancer and Cholesterol Drugs as Cost Savings Opportunity

Express Scripts, the nation’s largest pharmacy benefit manager (PBM), is looking for savings from new treatments for cancer and high cholesterol.

Now that Express Scripts and CVS Health, the nation’s second largest PBM, have negotiated discounts for new hepatitis C drugs, Express Scripts’ CEO said that new cholesterol and cancer drugs may be its next focus for negotiating discounts.

In December, Express Scripts announced that it would stop covering Gilead Sciences’ hepatitis C treatment Harvoni. The PBM struck a deal making AbbVie’s newly-approved Viekira Pak the exclusive option for its members with genotype 1 hepatitis C, in exchange for a discounted price. According to the company’s Chief Executive Officer George Paz, Express Scripts’ next cost-cutting targets include expensive new treatments for cancer and high cholesterol.

At the J.P. Morgan Healthcare Conference, Paz noted that the new cholesterol-lowering drugs, known as PCSK9 inhibitors, which significantly reduce bad cholesterol to low levels but are expensive, is an area of opportunity for cost savings. Like the new hepatitis C drugs, the PCSK9 medications are likely to enter the market around the same time, with Amgen and Regeneron in the lead and Pfizer not far behind. With high competition between these companies, PBMs will be in a position to impose pricing pressure to reduce costs.

However, Paz said that the big opportunity for cutting treatment costs is in cancer. He said that cost savings on cancer treatments could be achieved if the PBM were involved earlier in the decision making process. Currently, physicians run a patient’s cancer treatment regimen through a major medical benefits instead of through the PBM. However, according to Paz, if they did go through the PBM first, Express Scripts would get its doctors and pharmacists involved to ensure the prescribed regimens are appropriate. Although the physician makes the final decision, the PBM would advise on the most cost-effective, best regimen for the individual.

“The big opportunity out there is really in cancer,” said Paz. “If we can get out in front of that, that is a huge opportunity.”

Source: Specialty Pharma Journal

Roche acquires Trophos to expand portfolio in neuromuscular disease with high medical need

Swiss drugmaker Roche has signed an agreement to acquire privately-held Trophos for up to $545 million.

The acquisition will provide Roche with Trophos’ candidate for the rare and debilitating spinal muscular atrophy (SMA). Trophos’ proprietary screening platform generated olesoxime (TRO19622), which is in mid-stage development for SMA. SMA is a life-limiting and highly disabling genetic disease characterized by progressive muscle weakness and loss of motor function. It affects the motor neurons of the voluntary muscles used for activities like crawling, walking, head and neck control and swallowing. Typically the disease presents in early childhood, and is the most common genetic cause of infant mortality. SMA affects one in 6,000 to one in 10,000 children.

Results from a Phase II study of Trophos’ olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with the disease.

“SMA is a grievous disease with a huge impact on the daily life of patients and their families, who are currently left only with supportive care. We are proud to see the development of this medicine evolving, with the ultimate goal of a potential first medicine for SMA,” said Christine Placet, Chief Executive Officer at Trophos. “This is a tremendous recognition of the work done by Trophos’ teams and supporters over the past 16 years.”

Under the agreement, Roche will pay Trophos’ shareholders roughly $139 million upfront and contingent payments of up to $406 million based on achievement of certain milestones.

“This acquisition highlights Roche’s commitment to developing medicines for spinal muscular atrophy, a serious disease with no effective treatment,” said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development at Roche. “We will build on the work done by Trophos and the French Muscular Dystrophy Association to advance the development of olesoxime and to bring it to people who live with this devastating condition as quickly as possible.”

The acquisition marks Roche’s fourth deal announced this week. In addition Roche’s deal with Trophos, the company acquired a majority stake in Foundation Medicine for $1.2 billion, and obtained rights from Meji Seika Pharma and Fedora Pharmaceuticals to develop an early-stage infection disease compound for up to $750 million.

Source: Roche