Novartis-GSK business deal gets CCI nod

Novartis-GSK business deal gets CCI nod

 The Competition Commission of India (CCI) has approved a multi-billion dollar deal between global pharma giants GlaxoSmithKline Plc (GSK) and Novartis, as it did not find the transaction to be anti-competitive in India.

In its order dated 12 December, the fair trade watchdog said it is of the opinion that the "the proposed combination is not likely to have appreciable adverse effect on competition in India".

The three-part deal involves UK-based GSK acquiring the Swiss major's vaccine business and the latter purchasing GSK's cancer drugs portfolio, in a $16 billion deal.

The deal also involves purchase of the global human vaccines business of Novartis (excluding its influenza vaccines business) by GSK for an estimated of $7.1 billion.

Besides, the two drug majors have agreed to form a consumer healthcare joint venture in which GSK will own 63.5 per cent stake and Novartis the remaining 36.5 per cent.

GSK would contribute its global consumer health care business to the joint venture. This, however, would not include its consumer healthcare business in India.

Novartis will transfer its over-the-counter consumer healthcare business to the JV except for its products that are managed by and reported for financial purposes within Novartis' pharmaceutical division, Alcon division and Sandoz division.

CCI said "the negligible presence" of GSK and Novartis and "the presence of significant competitors, the vaccines transaction is not likely to result in appreciable adverse effect on competition in the market in India".

The regulator also observed that the presence of significant competitors in consumer healthcare segment does not cause concerns in relation to the proposed JV.

For the cancer drug portfolio, CCI observed that "there are no overlaps between the pipeline oncology products of the parties".

In India, GSK has been active through its various subsidiaries like Biddle Sawyer, GSK Asia, GSK Consumer Healthcare and GSK Pharmaceuticals.

Novartis is present in India through four entities - Novartis India, Novartis Healthcare, Sandoz Private Ltd and Chiron-Behring Vaccine Private Ltd.

Bristol-Myers Oncology Drug Opdivo Receives FDA Approval - Analyst Blog

Bristol-Myers Oncology Drug Opdivo Receives FDA Approval - Analyst Blog

Bristol-Myers Squibb Company ( BMY ) announced that the FDA has cleared its intravenous human programmed death receptor-1 (PD-1) blocking antibody, Opdivo for the treatment of patients suffering from unresectable or metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor.

Opdivo gained accelerated approval for the melanoma indication based on tumor response rate and the durability of response. Full approval for this indication depends on verification and description of clinical benefit in the confirmatory trials.

The company plans to start shipping the drug in next few weeks.

Opdivo is being studied in several oncology indications, such as, renal cell carcinoma, head and neck cancer, glioblastoma and non-Hodgkin lymphoma. We note that Opdivo is already approved in Japan for treating patients with unresectable melanoma.

The candidate is under review in the EU for the advanced melanoma and non-small cell lung cancer (NSCLC) indications. The company is also looking to get Opdivo approved for NSCLC in the U.S.

FDA approves Opdivo for advanced melanoma

FDA approves Opdivo for advanced melanoma

The U.S. Food and Drug Administration today granted accelerated approval to Opdivo (nivolumab), a new treatment for patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs.

Melanoma is the fifth most common type of cancer in the United States. It forms in the body’s melanocyte cells, which develop the skin’s pigment. The National Cancer Institute estimates that 76,100 Americans will be diagnosed with melanoma and 9,710 will die from the disease this year.

Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.

“Opdivo is the seventh new melanoma drug approved by the FDA since 2011,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The continued development and approval of novel therapies based on our increasing understanding of tumor immunology and molecular pathways are changing the treatment paradigm for serious and life-threatening diseases.”

Other FDA-approved treatments for melanoma include ipilimumab (2011), peginterferon alfa-2b (2011), vemurafenib (2011), dabrafenib (2013), trametinib (2013) and pembrolizumab (2014). Opdivo is being approved more than three months ahead of the prescription drug user fee goal date of March 30, 2015, the date when the agency was scheduled to complete its review of the application.

The FDA granted Opvido breakthrough therapy designation, priority review and orphan product designation because the sponsor demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies; the drug had the potential, at the time of the application was submitted, to be a significant improvement in safety or effectiveness in the treatment of a serious condition; and the drug is intended to treat a rare disease, respectively.

Opvido is being approved under the FDA’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts additional clinical trials to confirm the drug’s benefit.

Opdivo’s efficacy was demonstrated in 120 clinical trial participants with unresectable or metastatic melanoma. Results showed that 32 percent of participants receiving Opdivo had their tumors shrink (objective response rate). This effect lasted for more than six months in approximately one-third of the participants who experienced tumor shrinkage.  

Opdivo’s safety was evaluated in the overall trial population of 268 participants treated with Opdivo and 102 participants treated with chemotherapy. The most common side effects of the drug were rash, itching, cough, upper respiratory tract infections, and fluid retention (edema). The most serious side effects are severe immune-mediated side effects involving healthy organs, including the lung, colon, liver, kidneys and hormone-producing glands.

Opdivo is marketed by Princeton, New Jersey-based Bristol-Myers Squibb.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Competition Commission of India clears Novartis-GlaxoSmithKline pharma deal

Competition Commission of India clears Novartis-GlaxoSmithKline pharma deal

Fair trade regulator CCI has approved a multi-billion dollar deal between global pharma giants GlaxoSmithKline Plc and Novartis, as it did not find the transaction to be anti-competitive in India.

The multi-layered deal involves UK-based GlaxoSmithKline (GSK) acquiring the Swiss major's vaccine business, while the latter would purchase GSK's cancer drugs portfolio.

In a order dated December 12 and made public today, the Competition Commission of India (CCI) said it is of theopinion that the "the proposed combination is not likely to have appreciable adverse effect on competition in India".
The three-part deal involves acquisition of GSK's portfolio of oncology products by Novartis for $16 billion.
The deal also involves purchase of the global human vaccines business of Novartis (excluding its influenza vaccines business) by GSK for an estimated amount of $7.1 billion.

Besides, both the drung majors have entered into a agreement to form consumer healthcare joint venture in which GSK will own 63.5 per cent stake and Novartis would own the remaining 36.5 per cent holding.

GSK would contribute its global consumer health care business to the joint venture. However this would not include its consumer healthcare business in India.

Moreover, Novartis will transfer its over-the-counter consumer healthcare business to the JV except for its products that are managed by and reported for financial purposes within Novartis' pharmaceutical division, Alcon division and Sandoz division.
With regard to the vaccine deal, the CCI said that "the negligible presence" of GSK and Novartis and "the presence of significant competitors, the vaccines transaction is not likely to result in appreciable adverse effect on competition in the market in India".
The regulator also observed that the presence of significant competitors in consumer healthcare segment does not cause concerns in relation to the proposed JV.
For the cancer drug portfolio, CCI observed that "there are no overlaps between the pipeline oncology products of the parties".
In India, GSK has been active through its various subsidiaries like Biddle Sawyer, GSK Asia, GSK Consumer Healthcare and GSK Pharmaceuticals.
On the other hand, Novartis is present in India through four entities -- Novartis India, Novartis Healthcare, Sandoz Private Ltd and Chiron-Behring Vaccine Private Ltd.
The deal between the drug majors was entered into in April this year, following which they had approached CCI for its approval.

MorphoSys Announces Clinical Milestone in Oncology Program

MorphoSys Announces Clinical Milestone in Oncology Program

Prime Standard Segment, TecDAX, OTC: MPSYY) announced today that it has received a milestone payment from Novartis in connection with the initiation of a phase 1 clinical trial of a HuCAL antibody in the field of oncology. This becomes the tenth therapeutic antibody made using MorphoSys's technologies that Novartis is evaluating in clinical trials. The associated milestone payment is booked in 2014.

"In 2014 our pipeline, and our collaborators' pipelines of therapeutic antibodies have matured significantly and now include more programs in clinical trials and in a more advanced state than ever before. Today's news represents the fourth clinical milestone with our partners during the course of the year," commented Dr. Marlies Sproll, Chief Scientific Officer of MorphoSys AG.

MorphoSys's collaboration with Novartis has resulted in ten clinical programs to date, five of which are in phase 1 development, with another four programs in phase 2 and one in phase 3. In total, MorphoSys's partnered and proprietary clinical pipeline currently comprises 22 unique antibody molecules which are being evaluated in more than 60 clinical trials.

 

AstraZeneca eyes $2B in sales with FDA nod for ovarian cancer fighter Lynparza

AstraZeneca eyes $2B in sales with FDA nod for ovarian cancer fighter Lynparza

AstraZeneca ($AZN) won accelerated FDA approval for its ovarian cancer fighter Lynparza (olaparib), opening the door for potential blockbuster sales of the drug and helping the company distinguish itself from rivals in the BRCA playing field.

Lynparza belongs to a new class of treatments, poly ADP-ribose polymerase (PARP) inhibitors, which are designed to zero in on cancer cells and leave a patient's normal cells untouched. The drug snagged a regulatory signoff from the European Medicines Agency one day before its stateside approval, making it the first drug cleared in the U.S. to treat advanced ovarian cancer in women with defective BRCA genes. AstraZeneca expects Lynparza to bring in $2 billion a year in peak sales.

Briggs Morrison, AstraZeneca's chief medical officer, called Lynparza "an excellent example" of next-generation R&D into targeted medicines and "a much-needed" new option for patients with ovarian cancer. And AstraZeneca has even higher hopes for Lynparza down the road. "Today's approval also marks the first of what we hope will be a number of indications in which this medicine has the potential to improve the lives of cancer patients," Morrison said.

The FDA based its approval on a Phase II study comparing Lynparza to a placebo in BRCA-positive patients who'd relapsed after three rounds of chemotherapy. In the 137-patient study, the drug chalked up a 34% response rate, with half of patients responding for at least 7.9 months. The drug was approved alongside a companion diagnostic, BRACAnalysis CDx, from Myriad Genetics.

Regulators were not always rosy about Lynparza's prospects. Over the summer, an FDA panel voted 11-to-2 against early approval, citing questions about potential side effects and uncertainties about progression-free survival data. AstraZeneca bounced back with additional information showing Lynparza's success in treating patients who have failed chemotherapy three times and clearing the way for EMA and FDA approval.

The regulatory signoffs come at a critical moment for AstraZeneca, as the company touts its status as a solo act and beefs up its cancer drug portfolio. The U.K. drugmaker contends that Lynparza can bring in $2 billion a year, a figure it cited when fending off Pfizer's unwelcome pursuit, but it faces stiff competition from AbbVie ($ABBV) and Clovis Oncology ($CLVS), which are forging ahead with their own BRCA therapies. AstraZeneca appraises its overall oncology pipeline at $12 billion.

Meanwhile, AstraZeneca is testing Lynparza in a variety of cancers. In November, the Institute of Cancer Research's Johann de Bono touted promising results from an early clinical trial in prostate cancer. Late-stage studies are eyeing Lynparza in breast cancer, gastric cancer and pancreatic cancer. And in ovarian cancer, AstraZeneca has three Phase III studies underway, evaluating Lynparza as a treatment for relapsed patients and as a maintenance therapy.