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.

Wockhardt hits 52-week low

Shares of Wockhardt have dipped to its 52-week low at Rs 1,063, down 7% on the National Stock Exchange (NSE) in early morning trade in otherwise firm market.

Since January 15, 2016 the stock of drug maker has fallen 30% from Rs 1,515 after the US Food and Drugs Administration (FDA) raises concerns about manufacturing practices at the company’s Shendra plant in Maharashtra. The Nifty 50 index was down 0.28% during the period.

Wockhardt said that US FDA has made 9 observations for which appropriate reply would be submitted to inspecting authority in due course.

"Inspection of our manufacturing unit at E-1/1, MIDC, Shendra, Aurangabad by US FDA has since been completed. Further to inform you that Shendra manufacturing unit is a new facility and presently there are no supply of products from the said Unit to USA markets,” the company said in a regulatory filing on January 15.

Meanwhile, Wockhardt is schedule to announce its December 31, 2015 (Q3) quarter results on February 11, 2016.

At 09:56 AM, the stock was down 4.3% at Rs 1,094 as compared to 0.75% rise in Nifty 50 index. A combined 1.60 million shares changed hands on the counter on the NSE and BSE.

GSK Biologicals gets patent nod for pneumonia vaccine

GlaxoSmithKline Biologicals SA has received a favorable order from Indian Patent Office (IPO) for an invention related to improved Streptococcus Pneumonia vaccine. Patent Office, that has found out the company has removed all objections raised against the application stated ten claims submitted on 2nd June, 2015 stand granted for patent.

The company filed the application for "Comprising Streptococcus Pneumoniae Capsular Polysaccharide Conjugates' in June, 2008 and it was published on January, 2009, following which a first examination report was issued on March, 2011.In the first examination report, the Patent Office raised objections including 'claims lack novelty, inventive step and conflict with another application among others'.

The company argued claims in the application is different from that in other application it filed earlier and the claimed composition is new and provides an improved technical effect. The present invention optimises immune response elicited by different components in a pneumococal multivalent conjugate vaccine, argued the company.

The company also argued it is an object of the present invention to develop an improved formulation of a multiple serotype Streptococcus pneumoniae polysaccharide conjugate vaccine and the prior documents would not lead the skilled person to consider the particular composition of the claim to improve it and thus, the composition is novel and inventive.

After considering submissions during the hearing, Assistant Controller of Patents and Designs Abhijit Das issued an order granting the patent for ten claims submitted.
According to the documents, Streptococcus pneumoniae is the most common cause of invasive bacterial disease and Otitis media in infants and young children. Children less than two years of age do not mount an immune response to most polysaccharide vaccines, so it has been necessary to render the polysaccharides immunogenic by chemical conjugation to a protein carrier, it added.