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.