Bayer Receives FDA Approval for Kovaltry

 

Bayer Receives FDA Approval for Kovaltry® for the Treatment of Children and Adults with Hemophilia A

The U.S. Food and Drug Administration today approved Bayer’s Kovaltry® antihemophilic factor VIII (recombinant) for the treatment of hemophilia A in children and adults. Kovaltry is an unmodified, full-length recombinant factor VIII product. The approval is based on results from the LEOPOLD clinical trials, which demonstrated that Kovaltry controls bleeds, and reduces frequency of bleeding episodes with routine prophylaxis in children and adults with hemophilia A when used two or three times per week.

Bayer recently received approval of Kovaltry in Europe and Canada. Bayer is pursuing regulatory approvals of Kovaltry for the treatment of hemophilia A in further markets across the world. 

The approvals of Kovaltry build upon Bayer’s growing hematology portfolio which also includes Kogenate® Bayer, a product currently on the market in more than 70 countries, as well as a long-acting recombinant factor VIII pipeline candidate. Bayer is also pursuing alternative treatment approaches in preclinical and early clinical development, such as factor VIII gene therapy and inhibition of tissue factor pathway inhibitor (TFPI) in hemophilia, as well as in other blood disorders.

Amgen And UCB Announce Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With Osteoporosis

Amgen and UCB announced positive top-line results for romosozumab from the pivotal Phase 3 placeBo-contRolled study evaluatIng the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis (BRIDGE). These data showed the BRIDGE study met the primary endpoint, demonstrating a statistically significant increase in bone mineral density (BMD) at the lumbar spine (as assessed by dual energy x-ray absorptiometry) in men with osteoporosis treated with romosozumab compared with placebo at 12 months.

All secondary endpoints comparing romosozumab with placebo were also met. Patients receiving romosozumab experienced a statistically significant increase in BMD at the femoral neck and total hip at 12 months and a statistically significant increase in BMD at the lumbar spine, femoral neck, and total hip at six months, compared with those receiving placebo.

Romosozumab is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the protein sclerostin, and has a dual effect on bone, both increasing bone formation and decreasing bone breakdown. Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program includes two large fracture trials comparing romosozumab to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing romosozumab. 

Aurobindo Pharma gains on USFDA nod for Naproxen Sodium Tablets

Aurobindo Pharma has received final approval from the US Food & Drug Administration to manufacture and market Naproxen Sodium Tablets USP, 220 mg (OTC).

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product Aleve Tablets, of Bayer Healthcare LLC (Bayer), the release said.

Naproxen Sodium Tablets are used for treatment and prevention of osteoporosis in postmenopausal women. The approved product has an estimated market size of US $96 million for 12 months ended January 2016, according to IMS.

Bulk drug exports to grow 12-14% till 2018-19

India's bulk drug exports are likely to grow at an average rate of 12-14% till 2018-19 on the back of increasing shipments to countries including the US and Europe, an Assocham study said Monday.

Of late, the exports have shifted in favour of regulated markets evidently as there has been an increase in the share of these markets to about 49% in 2013-14 from about 43% in 2008-09, the Assocham-Yes Bank joint study said.

"India's bulk drug exports are likely to grow at a CAGR of 12-14% till 2018-19, driven largely by exports to regulated markets," The Associated Chambers of Commerce and Industry of India added.

The study also said that the domestic formulations market is likely to cross $20 billion mark by 2018-19 from a level of about $11 billion in 2013-14.

"The growth story of domestic formulations market is expected to remain strong, led by better healthcare diagnostic infrastructure," it added.

Indoco Remedies get US FDA nod for its Plant

Indoco Remedies has rallied 19% to Rs 314 on the National Stock Exchange (NSE) after the company received US Food and Drug Administration (USFDA) approval for Goa solid dosages plant.

“The company has received the Establishment Inspection Report (approval) from US Food and Drug Administration (USFDA) for its solid dosages manufacturing facility at Goa (Plant I),” Indoco Remedies said in a statement.

This plant has a capacity to manufacture 2.2 billion tablets, 32 million bottles of liquid orals, 16 million tubes of creams and ointments and 60 million capsules of hard gelatin. This plant has capability to manufacture aqueous, non-aqueous and photosensitive products.

Apart from approval from US FDA, this plant is also approved by UK-MHRA, MCC-South Africa, TGA-Australia and ANVISA-Brazil.

Johnson & Johnson Innovation Launches JLINX

Johnson & Johnson Innovation is expanding its company incubation strategy to include a new multifaceted initiative in Europe designed to identify and nurture early-stage companies actively pursuing research with the potential to transform human health. The initiative, a collaboration with Janssen Pharmaceutica NV, Inc. (Janssen), will be called Johnson & Johnson Innovation, JLINX (JLINX) and is designed to catalyze scientific innovations by offering start-ups flexible ways to grow and collaborate across the European life science ecosystem. 

JLINX will be located in a fully dedicated facility on the Janssen campus in Beerse, Belgium, and will be managed through a close collaboration between Johnson & Johnson Innovation and bioqube ventures, which will provide independent oversight for venture funding and company selection. JLINX will provide entrepreneurs with opportunities to share ideas and collaborate with each other while accessing a unique combination of resources including investment, infrastructure, and access to relevant internal and external scientific, technical and business expertise. The new initiative is accepting applications immediately and will be fully operational by this summer.

SANOFI AND REGENERON STRONGLY DISAGREE IN ONGOING PATENT LITIGATION REGARDING PRALUENT

Sanofi and Regeneron Pharmaceuticals, Inc. announced today that the companies strongly disagree with a U.S. District Court jury verdict that the asserted claims of two Amgen patents for antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) are valid. Sanofi and Regeneron believe these Amgen patent claims are invalid in the ongoing U.S. patent infringement lawsuit and plan to appeal the judgment.  This decision is the first step in this ongoing litigation and does not impact Praluent or our ability to deliver it to physicians and patients at this time.

 

"It has always been and remains our position that Amgen's asserted patent claims in this matter are invalid," said Karen Linehan, Executive Vice President and General Counsel, Sanofi.

Next steps on damages are to be determined. The judge will hold a hearing to consider a permanent injunction in the near future. 

"This is a complex area of law and science, and we believe the facts and controlling law support our position. We look forward to taking our case to the Federal Circuit Court of Appeals, the U.S. appellate court that hears all biopharmaceutical patent appeals," said Joseph LaRosa, Senior Vice President, General Counsel and Secretary, Regeneron. "Praluent was developed with Regeneron's proprietary science and technology and represents an important medical advance for patients."

In July 2015, Praluent was the first PCSK9 inhibitor to be approved for use in the U.S. It is indicated for use as adjunct to diet and maximally-tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of "bad" (LDL) cholesterol. Praluent is the only PCSK9 inhibitor available in two starting doses that allow physicians to adjust the dose based on a patient's LDL cholesterol lowering needs. The effect of Praluent on cardiovascular morbidity and mortality has not yet been determined.

PFIZER TO PRESENT NEW DATA ON INVESTIGATIONAL TOFACITINIB AT THE 11TH CONGRESS OF ECCO

Pfizer Inc announced today that seven abstracts reporting on new research for tofacitinib in ulcerative colitis (UC) and Crohn’s disease will be presented at the 11th Congress of ECCO, which will be held March 16-19 in Amsterdam, The Netherlands. Among the abstracts are detailed results from two pivotal Phase 3 studies from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis (OCTAVE) program. Tofacitinib is being studied as an investigational treatment for adult patients with moderate to severe active UC.

The full list of abstracts to be presented at the 11th Congress of ECCO follows:

Ulcerative Colitis

1. Efficacy and safety of oral tofacitinib as induction therapy in patients with moderate to severe ulcerative colitis: results from two phase 3 randomized controlled trials (OP019, Friday, March 18, 15:40 - 15:50)

2. Improvement in patient-reported outcomes in two phase 3 studies of tofacitinib in patients with moderately to severely active ulcerative colitis (P369, Friday, March 18, 12:20 - 13:20)

3. Tofacitinib plasma concentration monitoring is not needed for optimization of induction therapy in moderate to severe ulcerative colitis: results of pooled exposure-response analyses of phase 3 induction studies (DOP071, Friday, March 18, 18:54 - 19:01)

Crohn’s Disease

4. Efficacy and safety of oral tofacitinib for maintenance therapy in patients with moderate to severe Crohn’s disease: results of a phase 2b randomized placebo-controlled trial (OP021, Friday, March 18, 17:10 - 17:20)

5. Efficacy and safety of oral tofacitinib for induction therapy in patients with moderate to severe Crohn’s disease: results of a phase 2b randomized placebo-controlled trial (OP022, Friday, March 18, 17:20 - 17:30)

6. Effects of oral tofacitinib on patient-reported outcomes in patients with moderate to severe Crohn’s disease: results of two phase 2b randomized placebo-controlled trials (DOP053, Friday, March 18, 18:54 - 19:01)

7. Tofacitinib pharmacokinetics and durability of drug exposure in moderate to severe Crohn’s disease patients in phase 2 induction and maintenance studies (P428, Friday, March 18, 12:20 - 13:20)

US FDA warns Emcure Pharma

 

The US Food and Drug Administration (FDA) has warned Indian generic drugmaker Emcure Pharmaceuticals, saying it repeatedly fudget test records at its plant at Hinjwadi, Pune, in another case of pharmaceutical firm in the country facing such action.

In a letter, the FDA said its staff inspected Emcure's Hinjwadi plant where the company makes injectable drugs, between January 27 and February 4 last year and found "significant violations" of standard manufacturing practices. 

The agency had already banned imports from the plant in July, except for some drugs, such as the cancer medicine carmustine, the antipsychotic haloperidol, and the antibiotic amikacin. 

It is one of 42 drug-making factories in India that the FDA has banned in recent years as it stepped up inspections of foreign suppliers. The increased scrutiny has hit growth at Indian companies the hardest, as the country supplies nearly 40% of the medicines sold in the United States.

"We observed multiple examples of incomplete, inaccurate, or falsified laboratory records," the FDA said in the letter dated March 3 addressed to Emcure's Chief Executive 

Satish Mehta and posted on the US agency's website on Wednesday.

Unlisted Emcure, in which US private equity firm Bain Capital has a stake, declined to comment on the FDA letter.

The drugmaker committed to the FDA in 2014 that it would improve processes at its plant, the FDA said. Yet, in its 2015 inspection the FDA said it found "continuing practices of data falsification and manipulation at your facility, indicating that previous corrections were ineffective".

The fabricated records were of tests that Emcure was required to conduct to ensure proper environmental control was maintained while aseptic filling of drug batches, so that the products wouldn't become contaminated, the FDA said.

A plant employee told FDA inspectors that fabrication of records relating to environmental controls was "routine and due to work pressure", the agency said.

Emcure, which operates eight plants in India, supplies medicines to the United States, Europe, Brazil and Japan, according to its website 

The company has 15 days to respond to the FDA's letter on the corrective actions it will take on the concerns raised. It was not immediately clear what the consequences are if that deadline is not met.

Biocon to co-develop, produce recombinant human insulin

 

Biopharma company Biocon has tied up with Mexico's Laboratorios PiSA S.A. de C.V (PiSA) to jointly develop and sell a generic recombinant human insulin in the United States, a $2-billion market, one of the largest for insulin worldwide.

Biocon expects the insulin product by 2020 in the US, which accounts for nearly 40% share of the global $ 5 billion insulin market.

PiSA, a market leader in Mexico, is an existing partner for over a decade with Biocon. Biocon's Insulin Glargine was the first to be approved in Mexico in 2015, as per the new bio-comparable approvals pathway. Both companies are committed to providing affordable access to insulins to patients, the company said in a statement.

“The insulin market is dominated by a handful of players - Novo Nordisk, Eli Lilly and Sanofi. We believe we have the capacity and the size to play a significant role in the insulin market in the world," Kiran Mazumdar-Shaw, Biocon Chairperson and managing director told a conference call on Thursday.

"It is an expensive process. All the biosimilars development for the US market is upwards of $ 30 million. We have tied up with PiSA where we get added advantage of cost of commercialisation" she said.

Biocon has a cost and profit sharing model with PiSA, which will make the final product for the US market. The India and the upcoming Malaysian facility will produce the drug substance.

The Bengaluru-based Biocon already has over 50% market share in RH insulin in Mexico and nearly 30-40% share in southeast Asia and other Latin American markets.

“The US is the best market for RH human insulin because of the pricing. It is a over-the-counter (OTC) and institutional market. It plays well for Biocon's strength, said Shaw.

Biocon, which had completed phase three trials in Europe for the RH insulin, would now use data from the trials to develop the insulin for the US after new European guidelines made the market unattractive for the company.

"Today, the price point for RH insulin in the US is over $ 100, in India, it is a fraction of it. Obviously, development costs for the US will make it more expensive than the Indian price," said Shaw. "We see an opportunity to market it in the US with a judicious discounting of the product."

Orchid Pharma gets USFDA nod for Parkinson's drug

Orchid Pharma has announced it has received final approval from the US drug regulator to its Rasagiline Tablets 0.5 mg and 1 mg for treating symptoms of Parkinson's disease.

The product is a first-to-file application with a 180-day shared exclusivity, it said.

The company received approval for its Abbreviated New Drug Application (ANDA), an application for approval of a generic drug in the US, for Rasagiline tablets, upto particular strenght.

The company is expected to launch its product in the fourth quarter of 2016-17 fiscal.

Rasagiline Mesylate tablets are indicated for treatment of signs and symptoms of idiopathic Parkinson's disease.

"With a market size of over $300 million and limited generic competition, Orchid hopes to garner a decent market share from this product launch," said the company.

Baxter Enrolls First Patient in U.S. Clinical Trial for VIVIA Investigational Home Hemodialysis System

 

Baxter International Inc announced enrollment of the first patient in a U.S. clinical trial for VIVIA, an investigational home hemodialysis (HD) system being developed by Baxter and DEKA Research & Development Corporation.

The trial is designed to study more frequent, extended duration nocturnal home HD therapy (High Dose HD), which will be performed in dialysis facilities as well as the home setting. The study is assessing safety of the product and adequacy of dialysis.

The VIVIA investigational home hemodialysis system includes an integrated water purification module, safety sensors and one-button fluid infusion. The investigational system also features SHARESOURCE, Baxter’s two-way connectivity platform that allows physicians and nurses to monitor patients’ historical treatment results remotely.

ABBOTT'S ABSORB™ EARNS POSITIVE REVIEW BY FDA ADVISORY COMMITTEE

Abbott announced that an independent panel of experts convened by the U.S. Food and Drug Administration (FDA) voted 9 to 0, with one abstention, that the benefits of Abbott's Absorb fully bioresorbable drug eluting coronary stent outweigh the risks.

Absorb is a first-of-its-kind bioresorbable device for the treatment of coronary artery disease, which affects millions of adults nationwide and remains a leading cause of death despite decades of therapeutic advances. While most stents are made of metal, Abbott's Absorb stent is made of a naturally dissolvable material. Absorb dissolves completely after 2 to 3 years, once it has done its job of keeping a clogged artery open and promoting healing of the artery. By contrast, metal stents are permanent implants that restrict vessel motion by caging the artery for the life of the individual treated.

The FDA panel also voted on the device's safety and efficacy as a treatment for coronary artery disease. On the question of whether there is reasonable assurance that the device is safe, the vote was 9 to 1 in favor. On the separate question of whether there is reasonable assurance that the device is efficacious, the vote was 10 to 0 in favor. 

Chugai receives Orphan Drug Designation for Tocilizumab

Chugai Pharmaceutical Co announced that it received from the Minister of Health, Labour and Welfare, a notification of orphan drug designation for human anti-human IL-6 receptor monoclonal antibody "tocilizumab," a drug under development for treatment of systemic scleroderma.

Systemic scleroderma is designated as an intractable disease, by the Ministry of Health, Labour and Welfare. It manifests skin hardening, and internal organs are affected associated with its progression. Its etiology is yet to be fully elucidated. Current therapeutic options are only symptomatic in nature, such as corticosteroids and immunosuppressants and no established treatment is in place that can alleviate signs and symptoms as a whole. A new therapeutic agent with improved efficacy has been long awaited.

Chugai has been engaged in clinical development of tocilizumab as a drug for systemic scleroderma, in cooperation with its strategic alliance partner, Roche. A Phase III placebo-controlled clinical trial "focuSSced" is now under way. In February 2015, the results of the previous study, a Phase II clinical trial "faSScinate" indicated the possibility of improved efficacy of tocilizumab compared to existing drugs. Based on this finding, tocilizumab has been designated as a "Breakthrough Therapy" by the U.S. Food and Drug Administration. 

MENARINI ANNOUNCES THE FOUNDING OF VAXYNETHIC, JOINT VENTURE WITH BIOSYNTH

The Menarini Group announces the founding of VaxYnethic, a joint venture between Menarini NewTech and BiosYnth, pioneer company operating in the field of technologies for the production of conjugated vaccines.

VaxYnethic, taking full advantage of the technological know how of BiosYnth and Menarini, will be engaged in a medium to long term research project on an innovative technological platform for the production of biopharmaceuticals. The objective of the project is to work on a new technology which will allow researchers to expedite the production processes of biopharmaceuticals, as well as co-operate with other market players in order to reduce the manufacturing time for vaccines and satisfy the ever growing demand on a worldwide scale.

Menarini’s interest in high technology is not new. In 2013 The Menarini Group acquired the Silicon Biosystems Menarini start up, a company which operates in the field of personalised medicine and holder of the patent on the DEPArray™ system which allows researchers to carry out a precise analysis of rare tumour cells. Later, in 2014, Menarini Biomarkers was founded, a company which currently conducts research projects on new biomarkers for the development of personalised medicine with the support of the DEPArray™ system.

Reasons for Daraprim still costs USD 750 a pill

Since the news that Turing Pharmaceuticals had jacked up the price of the drug Daraprim by 5,000% broke in September, former CEO Martin Shkreli has become perhaps the most-hated public figure in America, resigned from his job and been arrested on civil and criminal securities fraud charges.

While much has changed in Shkreli’s life, when he testifies before the House Committee on Oversight and Government Reform on Thursday those who use Daraprim will be paying the exact same price they’ve paid for the last four months: $750 per pill. Fresh from drubbings in the press and presidential candidates, Shkreli said in late September that he would cut the cost of the drug, which cost $13.50 a pop before Turing acquired it and which many patients must take daily for years.

He didn’t say how much the price would be lowered, but it didn’t matter—he would swiftly renege on is promise. In late November, Turing announced discounts of up to 50% for hospitals—where only patients requiring hospitalization would benefit from the reduction—along with smaller, less costly bottles of the drug. The embattled biopharmaceutical company sought to portray its price hike as costly only to insurance companies and not consumers, according to documents.

The company also established patient assistance programs to take the focus away from what a 5,000% increase in price seemed likely to do to patient access, said the memo, which summarized more than 250,000 pages of Turing documents. But patients were still slapped with co-pays ranging from $1,000 to even more than $16,000, according to the memo. Access to the drug has also been impeded on the state level, where health departments—normally eligible for discounted Medicaid rates on drugs—have had difficulty gaining access, said Sean Dickson, manager of health care access at the National Alliance of State and Territorial AIDS Directors. And while hospitals can get discounted access to Daraprim, those terms are negotiated individually, and would only benefit patients getting initial treatment with the drug. 

Daraprim is used to treat parasitic infections and prevent a nervous system infection in those with HIV.