Cipla to acquire US generic business

Cipla has acquired two US-based generic drug companies -- InvaGen Pharmaceuticals Inc., and Exelan Pharmaceuticals Inc for a total value of $550 M.

InvaGen & Exelan Pharmaceuticals    owned by the promoter of Hyderabad-based drug maker Hetero Drugs Ltd.  InvaGen acquisition  provides Cipla with an access to large wholesalers/retailers in the US. While, the acquisition of Exelan Pharmaceuticals provides Cipla access to the government and institutional market in the US . The combined revenue  of these  two companies  were approx  $200 M in 2014.  

InvaGen Pharmaceuticals is not linked directly to the flagship companies of Hetero group, Hetero  likely to  continue to strengthen its  US  presence  by investing  in  its subsidiary firm Camber Pharmaceuticals Inc.

Evonik to Acquire Monarch Catalyst of India

Evonik Industries   to strengthen its global catalysts business, has signed an agreement with Monarch Catalyst Pvt. Ltd., India to acquire 100% of the company’s shares. The transaction is expected to close during the first half year of 2015 subjected to  regulatory approvals.

Evonik with its Business Line Catalysts is a global leader in producing specialty catalysts, custom catalysts and catalysts components for the Life Sciences & Fine Chemicals, Industrial & Petrochemical and Polyolefines market segments. This bolt-on acquisition in India with annual sales in the low double-digit million € range complements Evonik’s leading positions in activated base metal catalysts and precious metal catalysts. Monarch’s global oils & fats hydrogenation catalysts business is a broadening of the Evonik catalysts portfolio. Monarch Catalyst has about 300 employees.

Govt of India caps prices of 52 more 'essential' drugs

In order to   further tighten   the  prices of essential medicines, the government of India  has brought 52 new drugs under its price control mechanism including some commonly used painkillers, antibiotics and few for  treatment of cancer , cardiovascular and skin diseases. 

These  additional  52 drugs join a list of nearly  earlier 400 essential medicines that have so far been placed under price control in India.  Now  more than 450 drug formulation packs are  under the price control mechanism of the National Pharmaceutical Pricing Authority (NPPA), which entails the regulator fixing ceiling and retail prices for such medicines.

"The NPPA has fixed/revised the prices in respect of 52 formulation packs both ceiling and retail price packs under DPCO, 2013," the drug pricing regulator said.

The bulk drug formulations that have been added to the controlled list include those containing Paracetamol, Glucose, Amoxycilline, Diazepam, Codeine Phosphate, Ciprofloxacin, Losartan, Diclofenac,  Atoravastatin  &   Rosurvastatin.

Earlier in September 2014, NPPA had capped the prices of 43 formulation packs including drugs such as antibiotic Ciprofloxacin, BCG vaccine and anti-diabetic Metformin.

In July 2014  also, NPPA had reduced the prices of some of the key medicines and had fixed the price of 108 non-scheduled formulation packs of 50 anti-diabetes and cardiac medicines.

Dengue drug can give Sanofi Multi Billion $ biz

As India deals with increasing number of dengue fever, pharma major  Sanofi  announced that the world's first vaccine against the mosquito-borne viral disease may be available by the second half of 2015.  Sanofi  will file for registration of its vaccine candidate and subject to regulatory approval the world's first dengue vaccine could be available by the late  H1 or early H2  of 2015.

According to the company’s release, analyses had shown a 95.5 per cent protection against severe dengue and an 80.3 per cent reduction in the risk of hospitalisation during the study.

Dengue, a mosquito-borne viral disease, has been estimated to be a billion-dollar burden every year in India, with no specific treatment.  It is a health priority in many countries of Asia & Latin America.  According to WHO, dengue threatens over 2.5 billion people worldwide, including an estimated 500,000 who are hospitalised every year from the disease. Between 2 and 3 of every 100 people who contract dengue end up dying from it.

  

WHO estimates up to 100 million infections yearly, of which about 6M cases are from India alone.  However a large study published in 2013, for  2010, an estimated third of all dengue infections were in India, and the situation has worsened since. According to Health Ministry data, the number of dengue cases jumped 500 per cent from 12,561 in 2008 to 75,808 in 2013. Both the disease and deaths are, however, suspected to be under-reported, and some experts feel the incidence of dengue in India could be up to 300 times higher.

With no specific treatment available, the management of dengue has been largely preventive, through anti-mosquito activities, or symptomatic, where doctors treat patients for the symptoms. A vaccine, according to the WHO, “would, therefore, represent a major advance in the control of the disease”.

While India itself would be a big opportunity for Sanofi on the vaccine, the opportunities elsewhere are also handsome. Brazil, Australia and Southeast Asian countries are also hugely affected by the disease thus opening up a Multi Billion opportunity for Sanofi.

FMC Corporation Announces Separation into Two Independent Public Companies

FMC Corporation Announces Separation into Two Independent Public Companies

New FMC will be comprised of FMC Agricultural Solutions and FMC Health and Nutrition segments FMC Minerals will be comprised of the current FMC Minerals segment, which includes the Alkali Chemicals and Lithium businesses PHILADELPHIA, March 10, 2014 /PRNewswire/ -- FMC Corporation (NYSE: FMC) today announced plans to separate into two independent public companies, "New FMC," which will be comprised of FMC's Agricultural Solutions and Health and Nutrition segments and "FMC Minerals," which will be comprised of FMC's current Minerals segment.  The company expects the separation, which remains subject to final board approval and other customary conditions, will take the form of a tax-free distribution of shares to existing FMC shareholders.  FMC Corporation expects to complete the separation in early 2015, and each company is expected to be listed on the New York Stock Exchange.  Pierre Brondeau, FMC Corporation president, CEO and chairman, said: "FMC has proactively managed its portfolio during the last four years as part of Vision 2015, including a realignment of our reporting segments early last year.  Our decision to separate into two independent companies is a natural progression of our strategy. We believe that creating two companies, each with its own publicly-listed equity, will enable the management of each company to pursue its own strategy. This will give each company greater focus on the success factors that are most important to its business and allow the adoption of a capital structure that is appropriate to its business profile. "The creation of two independent companies will deliver meaningful benefits to each of the businesses, the communities in which we operate and all of our stakeholders. Our customers will continue to have collaborative relationships with financially strong organizations that are focused on meeting their needs, and our employees will have new career opportunities."   New FMC New FMC, comprised of FMC Agricultural Solutions and FMC Health and Nutrition segments, will be a technology-based and customer-driven company with deep application expertise. Based on the midpoint of the company's February 2014 outlook, combined revenue and earnings for the Agricultural Solutions and Health and Nutrition segments are expected to be approximately $3.35 billion, up 16 percent over 2013, and $815 million, up 15 percent over 2013, respectively.  New FMC is expected to maintain a strong balance sheet and financial policies consistent with FMC Corporation's current credit rating.  FMC Agricultural Solutions is a science-based business, serving growers worldwide. Growers look to FMC Agricultural Solutions for innovative crop-protection products developed from science-based innovation, field development, applications expertise and toxicology that, on a crop-by-crop, region-by-region basis, enhance quality and yield. FMC Health and Nutrition develops products from natural sources that provide texture, stability and natural color solutions for food applications, while also producing binders, coatings and high-purity, high-concentration omega-3 for pharmaceutical and nutraceutical applications. Customers rely on FMC Health and Nutrition for its technical excellence, innovative products and collaborative R&D approach. FMC Minerals FMC Minerals will be comprised of the current FMC Minerals segment, which includes the Alkali Chemicals and Lithium businesses. Based on the midpoint of the company's February 2014 outlook, revenue and earnings for the FMC Minerals segment are expected to be approximately $1.0 billion, up 7 percent over 2013, and $153 million, up 19 percent over 2013, respectively. FMC Minerals is expected to generate strong cash flow and have the financial flexibility to pursue select investment opportunities. FMC Minerals will maintain FMC Corporation's disciplined approach to capital deployment and will continue to focus on sustainable, safe and ethical extraction of minerals, process efficiencies, and manufacturing and customer service excellence. Both the Alkali Chemicals and Lithium businesses are structurally-advantaged minerals businesses, with cost-advantaged operations. Both businesses compete in attractive markets.  The Alkali Chemicals business is the largest global producer of natural soda ash, using low-cost technologies to extract trona ore to produce soda ash and related products used in the glass, chemical processing and detergent industries. The Lithium business is the only brine-to-metals producer with a broad global product portfolio, selling into the energy storage, pharmaceuticals, polymers and industrial markets. Underlying market demand for lithium remains strong, driven by growth in energy storage from electric vehicle adoption and other applications. Bank of America Merrill Lynch and Goldman Sachs are acting as financial advisors to FMC Corporation on the proposed transaction and Wachtell, Lipton, Rosen & Katz is serving as legal advisor to the company. source : FMC site

USFDA increases inspections of drug facilities in India

USFDA  is increasing its inspections of facilities of drug makers in India, the second largest provider of finished dose products to the US, to ensure compliance of approved manufacturing norms. The US health regulator, which has been cracking the whip against many Indian pharmaceutical firms, including Ranbaxy, Wockhardt, is also recruiting and training additional drugs investigators in India. 

USFDA's presence in India is being increased to 19 from 12 American staff based in-country, including 10 dedicated specifically to medical products. Other staff include foods and devices inspectors, and policy analysts. 

In order to meet requirements of the new Food and Drug Administration Safety and Innovation Act (FDASIA) - Generic Drug User Fee Amendments (GDUFA), the US health regulator is stepping up the inspections. Under the FDASIA, the USFDA is required to achieve the same inspectional schedule for foreign facilities as domestic manufacturers, and to clear the backlog of applications by the end of the first five-year user fee authorisation period. 

India, as the second largest provider of finished dose products to the US with almost 10

per cent of that market.

The new Drug Pricing. Battle Escalates !

Several pharma  companies  & Industry bodies like Indian Drug Manufacturers Association, Confederation of Indian Pharmaceutical Industry (CIPI)  already moved  to Court  and  few more expected join, to challenge the government's new drug pricing order that asked them to slash prices of 348 medicines and also  replace stocks in the market with those carrying reduced prices within 45 days of new price notification. 

The DCPO had ordered  earlier for reduction of prices of some medicines within 45 days of issuance of the  notification and that the decreased prices be made effective on drugs already in market.The deadline for  implementation of the notification ended on July 29.

Earlier  Indian Pharmaceutical Alliance,  estimated that with the application of the new price fixation methodology on a completely new set of medicines may see the Rs 100,000-crore industry losing about Rs 2,500 crore in revenues in the near term. Market intelligence firm AIOCD-AWACS estimates that the new price control system may hit the domestic revenues of majors Ranbaxy and Cipla by 6.2 and 5.8 per cent, respectively. 

 
Prices of 348 medicines, including life saving drugs are set to be cheaper by up to 80 per cent as the new Drug Price Control Order has come into effect.

As India pushes for compulsory drug licences,others looking for the new twists

The fight over drug patents in India is quickly spreading to  other areas  as other countries are looking at new twists on the model for getting their hands on cheaper drugs.

BDR Pharmaceuticals  has asked the Indian patent office to give it a compulsory license for a generic version of  BMS’s  cancer drug Sprycel (Dasatinib). Earlier Indian Supreme Court upheld the country’s first compulsory license granted last year to Natco Pharma to make a generic version of Bayer's kidney cancer drug Nexvar. It justified the decision to override the patent on prices. Natco began selling Nexavar for $170 a month, compared with Bayer's $5,000/month.

Others companies have also seen patents breached in recent months. Pfizer suffered the loss of IP protections on its cancer drug Sutent ( Challengers : Cipla & Natco ) and Roche's patent coverage on the hepatitis C treatment Pegasys been revoked.(Challengers : Sankalp Rehabilitation Trust)  Novartis  is still fighting for patent protection on its blood cancer treatment Gleevec (Challengers : Several Indian drug companies, Government of India)   and the Indian government has moved toward compulsory licenses on Roche's Herceptin.

Proponents of the aggressive attacks on patents say it is the only way for poor people in emerging countries to have a chance of getting the same lifesaving treatments that others in the world enjoy. It is an argument that has traveled well. 

China granted itself compulsory licensing rights last year but has yet to exercise them. Now a lobbying group is pushing Greece to adopt a compulsory license law, but not so Greek companies could make generics. The idea is that once the patents are neutralized, Greece could import cheap generics from other countries, like India.

Under India’s patent rules, compulsory licences can be issued when an inventor company fails to supply products at an affordable price. In such instances, other companies can go to court to get a licence to make the same products.

Reacting to  the such developments some U.S. Congress members said if India is going to continue to play loose with patent protections, maybe the U.S. needs to rethink an exemption for India on import duties that comes up for renewal in July.

Indian Regulator sets deadline for drug launches

Pharmaceutical companies will have to launch drugs within six months of getting approval from the drug regulator, failing which they could lose the manufacturing license.   According to the Indian Drugs and Cosmetics Act, for any new drug, pharmaceutical firms should file a periodic safety update report (PSUR) every six months, for the first two years and  once in a year for the subsequent two years.  This enables authorities to monitor the safety and efficacy of a new drug in a post-marketing scenario for four years, after which it no longer remains a new drug.

“It has been decided in public interest that in case an applicant/manufacturer fails to launch the product for marketing in the country within a period of six months from obtaining the permission or license, the permission/licence will be treated as cancelled,” said the DCGI

AstraZeneca's Cancer drug Patent Plea Rejected in India

In a setback to AstraZeneca, the Intellectual Property Appellate Board (IPAB) has dismissed its appeal against an earlier ruling that refused it a patent on lung cancer drug Gefitinib. The Indian patents office in 2007 refused patent protection to AstraZeneca, citing lack of invention. The Intellectual Property Appellate Board (IPAB) now upheld the refusal.

In its appeal, Astra Zeneca earlier had argued the controller had erred on various aspects of patent determination and also in concluding that the comparison test did not establish increased efficacy of the drug.

Innovators  suffered a reversal in March when India granted the first ever compulsory licence to Natco Pharma to sell Bayer's cancer drug Nexavar  equiavalent. Bayer has appealed  against the order.

And early this month IPAB revoked a six-year-old Indian patent granted to Roche's hepatitis C drug Pegasys, citing lack of evidence that the drug was any better than existing treatments.

Source:  newspaper & media reports

Generic drug manufactures to pay more for registration in US

US FDA recently made amendments to introduce a generic drug user fee. According to the new law, The Generic Drugs User Fee Amendment (GDUFA) of 2012 — companies will have to pay a fee ranging between $17,435 and $51,520 an application to seek an approval. Besides, drug makers will also have to pay for inspection of their facilities by the FDA outside the US, and for supplying active pharmaceutical ingredients (APIs) for manufacturing generic drugs in the US.

According to US FDA, companies will have to pay $17,434 per generic drug application pending without tentative approval till October 1. For applications seeking generic drug approval on or after October 1, companies will have to pay $51,520, whereas for Drug Master File companies are required to pay $21,340.

OTC sale of around 92 antibiotic and anti-TB drugs will be clamped down in India soon

Resistance to antibiotics is becoming a serious threat to Indians because of popular habit to pop pills at will which is an irrational use.  A recent study by the Centre for Disease Dynamics, Economics and Policy, said there has been a six-fold increase in the number of antibiotics being popped by Indians.

In order to avoid such irrational use, DCGI has written to the Union health minister to notify a new schedule H1 in the Drugs and Cosmetics Rules. Once notified and following the clearance from the law ministry, these drugs cannot be sold without prescription. These drugs will also have to carry a prominent label in red colour with the following warning: "It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the registered medical practitioner."

This is a very welcome news as we and world, staring at a post-antibiotic era, when common infections will no longer have a cure.

Source : Media reports

Pollution-related issues are haunting few AP Pharma units

While the Visakhapatnam district administration has sought the closure of the Mylan unit along with four other units in the pharma city operated by Ramky, the Andhra Pradesh Pollution Control Board (APPCB) has issued closure notices to 12 units around Hyderabad.


It is believed that villagers near Ramky’s Vizag pharma city have been complaining that the units there pollute air, affecting their health. In response, the district administration swung into action to verify the veracity of their allegations. According to sources, the APPCB, acting on the district administration’s request, conducted a study and confirmed air pollution. This led to immediate closure notices for five units (belonging to Mylan, Vegesna Laboratories, Actus Pharma, Vijay Organics and Acacia Life Sciences, respectively).

The Andhra Pradesh Pollution Control Board (APPCB) has issued closure notices to 12 bulk drug units located in Hyderabad while directing their managements to stop all the industrial activities by July 23, 2012. Of the 12 bulk drug manufacturing units currently under the PCB axe, two units belong to Aurobindo Pharma while four units are of Hetero Drugs Limited.

The units involving other companies are Crix Pharmaceuticals, Covalent Laboratories, Divis Pharmaceuticals, Krishna Pharmaceuticals, Innogent Laboratories and SMS Pharma Limited.

In a press release, the board said that these units were asked to close down under the Water & Air Acts in the interest of protecting public health and environment. “After detailed discussions, the board is of the firm opinion that certain industries are violating the orders of the Supreme Court of India and the ban notification issued by the Andhra Pradesh government, among others,” the press release said.

 
( source:   news  papers and  press releases)

Another Block buster bites the dust

Yet another milestone on pharma's journey away from the mega blockbuster era: Plavix (the world's second-best-selling medicine) goes off patent. And unlike Pfizer BMS plans to back off Plavix marketing immediately. Thanks to the monopoly Plavix enjoyed, USD 9 Billion on its peak and it brought in $6.6 billion in net U.S. sales last year and the drug has generated an estimated $42.8 billion for the company during its 15 years on the market.

FDA said it gave seven companies permission to sell generic Plavix or clopidogrel in the standard 75-milligram dose. According to the FDA, 75-milligram generic Plavix can now be sold by Apotex Corp., Aurobindo Pharma, Mylan Pharmaceuticals, Roxanne Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals.

The larger dose of 300 mg will be sold by Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan and Teva.