Category — Pharmaceuticals

Biocon (a Biotechnology Company with headquarters in Bangalore, India) has received the marketing authorization from the Drugs Controller general of India for  Novel Biologic Itolizumab (used for the treatment of chronic plaque Psoriasis). Itolizumab has an excellent safety profile as indicated during the 52-week clinical study conducted in India.

This approval paves the way for the launch, later in 2013, of Biocon’s Alzumab (a differentiated biologic drug) in India. It will treat moderate-to-severe Psoriasis and will be manufactured at the company’s facility in Bangalore.

According to Kiran Mazumdar-Shaw, Managing Director of Biocon, this is the company’s second novel biologic that they have developed in India after BioMab EGFR which is an anti-cancer monoclonal antibody.

Larsen & Toubro, Hindustan Unilever, Infosys, Tata Consultancy Services and Sun Pharma have made it on Forbes magazine’s list of world’s 50 most innovative firms. L&T led the list as 9^th place, followed by HUL (12^th), Infosys (19^th), Tata Consultancy Services (29^th) and Sun Pharma (38^th). Note that Hindustan Unilever is a subsidiary of European giant Unilever, but it largely run as a separate business. Larsen & Toubro was started in the 1930s by two Danish immigrants to India but is 100% an Indian company.

Forbes used the “Innovation Premium” to rank firms, which is calculated first by projecting a company’s income from existing businesses, plus anticipated growth from those businesses, and look at the net present value of those cash flows. U.S. companies dominated with the top 7 positions, followed by one each from India, China and Japan.

India’s SMS Pharmaceuticals confirmed that it has sold its manufacturing units in Visakhapatnam, Andhra Pradesh, to U.S. generic drugmaker Mylan Laboratories for $33 million. The unit is makes bulk drugs and formulations for cancer treatment.  The deal is the  second Indian acquisition by Mylan after it acquired 71.5 % of  Matrix Laboratories, one of the world’s largest suppliers of active pharmaceutical ingredients , in 2006 for $736 million and was rebranded under the Mylan name last year to launch the US firm’s generic drugs onto the Indian market.
SMS Pharma is focused on API manufacturing and claims to be the single largest producer of anti-ulcer products. The firm has also expanded into CRAMS and set up an oncology API and formulations manufacturing facility. The funds from sale will help SMS Pharma strengthen its existing facilities, cut interest costs and overheads, as well as improving working capital.  The Visakhapatnam facility bought by Mylan is yet to be approved by the US Food and Drug Administration. SMS Pharma said that the sale will not have much impact on its revenues and “will create a path for strategic alliances with the multinational as well as business development by way of getting multiple products. SMS Pharma has seven manufacturing facilities and two R&D centers. Two manufacturing facilities, (in Hyderabad and Vijayanagarm districts) are approved by the FDA.

Earlier this year, U.S.  injectable generic drugs specialist Hospira reached an agreement to acquire an active pharmaceutical ingredient manufacturing facility, together with an associated R&D facility from India’s Orchid Chemicals & Pharmaceuticals, for  $200 million. Acquisition of the , US FDA-approved facility is expected to reduce Hospira’s costs, support continuity of supply of key antibiotic products and pave the way for future API development.

India’s Cipla and Ranbaxy Laboratories (owned by Japan’s Daiichi Sankyo)  both announced novel combination therapies for on World Malaria Day — with eyes on markets in India, Africa, South America and Southeast Asia.

The products — Ranbaxy’s Synriam and Cipla’s Meflian Plus — are combinations of existing molecules arterolane maleate +piperaquine phosphate (Ranbaxy’s drug) and artesunate + mefloquine (Cipla’s product), respectively. The two drugs reduce dosage to one tablet per day for three days as against 2-4 tablets daily that the other drugs require. Cipla’s drug has been introduced in partnership with the global research organisation Drugs for Neglected Diseases Initiative (DNDi), with the latter doing the clinical trials.

Business Today said, quoted Ranbaxy CEO Arun Sawhney that its product was “India’s first new chemical entity developed through clinical trials and commercialization in India”.

Synriam, priced at Rs. 130 ($1.60) for three tablets, is a three-day course.  The three-tablet module sets it apart from alternative therapies which require a 2-4 tablet dosage per day. Addressing the issue of price compared to competitors in the same category, Sawhney said that the drug is “the most economic therapy for malaria from the available options…there are some drugs that are priced at Rs.250 so compared to that this will be half of that.” This new drug, partially financed by the Department of Science and Technology of the Government of India, has been approved for marketing by the Drug Controller General of India (DGCI).

YK Hamied, CMD, Cipla, said Meflian Plus was targeted at resistant cases of malaria and that they would look at countries such as  Myanmar, Bangladesh, Thailand, Laos, Vietnam and Cambodia, where incidence of malaria is high.

According to the DNA India newspaper,  Revital and Volini are the leading brands for Ranbaxy, contributing to about 13% of its domestic sales, while for Cipla, Asthalin and Seroflo are the leading brands, making up 8% of its domestic sales.

What this means

This is simply a step in the journey of Indian drugmakers to become players on the world stage, beyond makers of generic drugs for the global market.

Bayer AG  of Germany is forming a joint venture in Mumbai with Cadila Healthcare Ltd to distribute pharmaceuticals in Indi.. Each company will hold 50 percent of the shares in the Mumbai-based venture, which will be called Bayer Zydus Pharma.  The 600 person entity will focus on women’s healthcare, diagnostic imaging, cardiovascular diseases, anti-diabetic treatments, and oncology. Bayer HealthCare AG CEO Jorg Reinhardt said that the company aims to significantly accelerate their capabilities to better serve the fast growing Indian market.