Bharat Biotech recalls combopack due to printing error

Mar 8, 2017 0

Hyderabad– Bharat Biotecha on Wednesday announced that it has voluntarily recalled a single batch of 40,000 vials of Combopack (Comvac 3 + BioHib) as a precautionary and safety measure due to wrong detailing on the carton printing.

The company said in a statement that the recall was made only because of printing error and not due to any quality issue. The vaccine is a Combopack of (Comvac 3 + BioHib) with two distinct component vaccine batches.

After a swift investigation, the company also informed the state drug authorities, center drug authorities and its CFA, marketing agents, vaccine administrators and doctors.

The company emphasised that there is no quality issue and the recall was purely because of printing error. (IANS)

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Cambridge biotech firm Visterra cancels plan for $50 million IPO, cites bad market conditions

Feb 10, 2017 0

CAMBRIDGE, MA– Visterra Inc., a Cambridge, MA-based clinical-stage biopharmaceutical company headed by CEO Brian Pereira, is cancelling its previously-announced plan for a $50 million Initial Public Offering, or IPO, citing bad market conditions, the Boston Business Journal reported.

“Visterra, a Cambridge biotech firm with an influenza treatment in a mid-stage trial, has withdrawn its plan for a $50 million initial public offering, according to a federal filing,” Boston Business Journal said.

Brian Pereira (Photo: Visterra website)

The BBJ report said that Visterra first disclosed its plan to raise between $46 million to $54 million on January 17, 2017. According to IPO fund manager Renaissance Capital, the company had been slated to go public the week of Jan. 23, listing on the NASDAQ under the symbol “VIST”.

“In a letter to the U.S. Securities and Exchange Commission on Friday, Visterra president and CEO Brian Pereira said that the company had changed course “due to market conditions unfavorable for the company to conduct its initial public offering, and the company’s determination that the registration of its securities is not in the best interests of the company at this time,” according to Boston Business Journal.

The local business newspaper quoted Visterra Chief Operating Officer and Chief Financial Officer David Arkowitz as saying in a separate statement that the company would “continue to consider and evaluate financing alternatives going forward, including a possible IPO at a future time.”

In January of 2016, Visterra said that it was planning to raise up to $69 million in an IPO, but that offering also failed to materialize, according to Boston Business Journal.

Visterra would have been the second Massachusetts-based biotech to go public in 2017 after Cambridge cancer drug developer Jounce Therapeutics (NASDAQ: JNCE), which raised $102 million on Jan. 27. Nine Massachusetts biotech firms went public in 2016 — two fewer IPOs than 2015 and eight fewer than 2014 — amid a broader decline in industry stocks, according to Boston Business Journal.

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Projects worth Rs 3,308 crore announced on first day of BioAsia

Feb 6, 2017 0

Hyderabad– BioAsia, Asia’s largest biotechnology and life-sciences forum, began here Monday with the announcement of projects worth Rs 3,308 crore.

The Telangana government signed a MoU with Cerestra to explore Life Sciences Infrastructure Fund to the tune of Rs 1,000 crore to create modular plug-and-play infrastructure for pharma/ biotech/ medical devices industry.

Projects entailing an investment of Rs 1,680 crore were launched at Genome Valley on the first day of the three-day event.

These include MN Park’s iHub Phase II with two million square feet of lab space for R&D companies and start-ups with an investment of about Rs 1,000 crore.

The Telangana government also handed over land allotment letters for about six companies which propose to make an investment of Rs 702 crore.

Building plans of country’s largest animal resource facility were also unveiled. The facility is being set up with the central government’s grant of Rs 330 crore while the state government is allotting 102 acres of land.

Biological E’s also conducted groundbreaking of its vaccine plant in Genome Valley with an investment of Rs 300 crore.

SME Hub @IKP was also launched in Genome Valley. The 50,000 square feet incubation facility for Life Sciences SMEs is coming up with an investment of Rs 50 crore.

The 14th edition of BioAsia with the theme ‘Power of the Past, Force of the Future’, was inaugurated by Governor E.S.L. Narasimhan in the presence of high profile industry leaders from government, corporate and regulatory bodies.

He also presented Genome Valley Excellence Award to Nobel Laureate Prof. Kurt Wuthrichand and Dr. Paul Stoffels, Worldwide Chairman Pharmaceuticals and Chief Scientific Officer of Johnson & Johnson for their contribution in the field of life sciences and healthcare.

The governor noted that over 200 MoUs worth Rs 14,000 crore investments have so far been announced at BioAsia since the inception of the event.

Telangana’s Industry Minister K.T. Rama Rao said Hyderabad had always been known as the top pharma destination worldwide. “The city is and will remain the pharma production and innovation hub for the world and the proposed Pharma City will strengthen its position significantly. With new industrial clusters like Pharma City and Medical Devices park, Hyderabad is ready to assume leadership role of the life sciences industry in Asia and the world,” he said.

Bio Asia CEO Shakthi Nagappan said they were excited to witness the overwhelming response to the 14th Edition of BioAsia in terms of participation, investments and strategic partnerships. (IANS)

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Biocon ranks among the world’s top 10 biotech employers

Oct 29, 2016 0

Bengaluru– India’s bio-pharma major Biocon Ltd has been ranked among the world’s top 10 employers in the biotechnology industry by an international science magazine on Friday.

According to a web-based annual survey by the magazine, the city-based company moved to ninth this year from 13 last year in the ‘Science 2016 Top Employer’ ranking, which is based on firms that are innovative leaders in the industry, are socially responsible and have a clear vision.

Kiran Mazumdar Shaw

Kiran Mazumdar Shaw

“The ranking is recognition of our high quality talent aligned with the vision of innovation-led enterprise that is socially responsible,” said Biocon Chairperson Kiran Mazumdar-Shaw in a statement here.

When the magazine asked what makes companies best, their employees asserted that top firms operate as meritocracies, have adequate resources, trusted brands and are responsive to their stakeholders.

“We believe that our employees are our great strength. Our work culture of unconventional thinking, focus on excellence, freedom of speech and empowerment instills confidence and ownership in our people,” added Shaw.

Of the top 10 employers, six are based in the US, two (Novo Nordisk and Novozymes) in Denmark and one (Roche) in Switzerland.

The US-based ranked biotech firms are Regeneron Pharmaceuticals, Moderna Therapeutics, Eli Lily, Vertex, Genetech and Alexion. (IANS)

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Biocon net up 17 percent in Q1

Jul 22, 2016 0

Bengaluru– India’s biotechnology major Biocon Ltd on Friday reported a Rs 147 crore consolidated net profit for April-June first quarter of fiscal 2016-17, registering a 17 per cent annual growth from Rs 126 crore in the like period year ago.

The city-based company said consolidated total revenue increased 11 per cent year-on-year (YoY) to Rs 952 crore for the quarter under review (Q1) from Rs 857 crore in same period year ago.

Kiran Mazumdar Shaw

Kiran Mazumdar Shaw

Total revenue includes net sales of Rs 903 crore, up 10 per cent YoY from Rs 825 crore, other income of Rs 49 crore, an increase of 52 per cent YoY from Rs 32 crore in same quarter year ago.

Ebitda (earnings before interest, tax, depreciation and amortisation) for Q1 has increased 15 per cent YoY to Rs 271 crore from Rs 236 crore same quarter year ago though its margin remained flat at 28 per cent YoY. Net profit margin also remained flat at 15 per cent YoY.

Of the total sales for the quarter under review (Q1), small molecules contributed Rs 357 crore, Syngene (research services) Rs 263 crore, branded formulations Rs.159 crore and biologics Rs 107 crore.

Income from licensing, including capacity reservation fee, however, declined 73 per cent YoY to Rs 17 crore from Rs 64 crore in same quarter year ago.

“Our strong performance in Q1 has been driven by an all-round growth of business across small molecules, biologics, branded formulations and research services,” said Biocon chairperson Kiran Mazumdar-Shaw in a statement here later.

The biopharma has filed its first biosimilar Pegfilgrastim in European Union during the quarter under review, while its Glargine insulin forayed in Japan.

“We have received regulatory approvals from Malaysia for commercialisation of rh-Insulin and Glagrine. We are also on track to file on our new biosimilars and generic formulations in the developed markets later this year,” Shaw noted.

The Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) has accepted Pegfilgrastim for review while Malaysian drug regulator approved Glargine.

“Our research and development (R&D) spend was Rs 92 crore, reflecting the progress of generic formulations, biosimilars and novel programmes,” Shaw added.

The company’s blue chip scrip of Rs 5 per share (face value) gained Rs 64.75 or 9.23 per cent to buy or sell at Rs 766 per share on the BSE as against Thursday’s closing price of Rs 701.50 and opening price of Rs 719.80 though it touched a high of Rs 771 and low of Rs 712 per share during pre-noon trading session.

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India’s Sun Pharma launches ready-to-administer cancer drug in Europe

Jul 11, 2016 0

Chennai– Drug major Sun Pharmaceutical Industries Ltd on Monday announced the launch of ready-to-administer cancer drug Gemcitabine InfuSMART in Europe.

In a statement, the company said InfuSMART is a technology in which oncology/cancer products were developed in a ready-to-administer bag.

“Until now, compounding of oncology products was done at compounding centres or compounded in hospital pharmacies, an extra step before the medicine can be administered to patients,” the company said.

Sun Pharma claimed that it is the world’s first pharmaceutical company to manufacture and launch a licensed ready-to-administer oncology product.

Over the next few months, Sun Pharma will launch Gemcitabine InfuSMART across Netherlands, Britain, Spain, Germany, Italy and France.

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Biocon net up whopping 79 percent in Q4

Apr 27, 2016 0

Bengaluru– Biotech major Biocon has posted profit of Rs.361 crore for the fourth quarter (January-April) of 2015-16, registering a whopping 79 percent growth year-on-year (YoY) from Rs.201 crore in the like period a year ago.

Revenue for the quarter under review (Q4), however, grew 17 percent YoY to Rs.1,004 crore from Rs.854 crore in same period year ago,” the city-based company said in a statement here on Wednesday.

For entire fiscal (FY 20-16), net profit shot up to Rs.896 crore from Rs.497 crore in previous fiscal (2015), registering 80 percent growth YoY, while revenue, however, grew 14 percent YoY to Rs.3,570 crore from Rs.3,143 crore year ago.

Earnings before interest, depreciation and amortization (Ebitda) for quarter increased 18 percent YoY Rs.238 crore from Rs.203 crore in like period and 21 percent YoY to Rs.903 crore for fiscal from Rs.749 crore year ago.

“Ebitda (operating) margin remained flat YoY for quarter at 24 percent and marginally one percent up to 25 percent for fiscal from 24 percent year ago,” the statement said.

Net profit margin 36 percent YoY for Q4 grew from 24 percent in like quarter year ago and to 25 percent YoY for fiscal from 16 percent year ago.

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Ankit Mahadevia’s Spero Therapeutics gets $30 million funding

Feb 3, 2016 0

CAMBRIDGE, MA– Spero Therapeutics, a biopharmaceutical company founded to develop novel therapies to treat bacterial infections, announced existing Series A investors Atlas Venture, SR One, MRL Ventures, Lundbeckfond Ventures, The Kraft Group and Partners Innovation Fund will provide $30 million in Preferred B funding.

Ankit Mahadevia

Ankit Mahadevia

“We are very privileged to have the strong support of our existing investors to close this Series B financing, which will allow us to continue to advance the important work we are doing to combat the global public health threat of antibiotic resistance.,” said Ankit Mahadevia, M.D., President and Chief Executive Officer of Spero. “Humankind is currently losing a race against bacteria now resistant to every known antibiotic—known as ‘Superbugs’—with immeasurable healthcare consequences if left unchecked. Spero is executing an aggressive effort to develop important therapies that differ mechanistically and functionally than available treatments in order to address this growing threat.”

Spero will use proceeds from this financing to further progress its unique therapeutic “Potentiator Platform,” intended to improve drug potency and enhance the utility of existing anti-infective medications. Funding will also enable the organization to advance efforts in support of its DHFR program which targets Gram-positive and negative bacteria, fungi and protists. The DHFR program seeks to expand a novel antifolate’s antibacterial spectrum to treat trimethoprim-resistant isolates including key Gram-negative pathogens.

“Spero is making excellent progress in its effort to create novel therapies to combat severe infections by reinvigorating existing antibiotics and returning their relevance within the field of anti-infectives,” said Jean-François Formela, M.D., Partner at Atlas Venture. “We are excited to continue working with a company doing truly innovative work that has the potential to fulfill such an important unmet medical need.”

Added Rez Halse, Ph.D., Partner at MRL Ventures: “The unanimous reinvestment decision among Series A backers is a reflection of the promise and progress made to date. The unique Spero Potentiator Program, and other early stage efforts offer the potential to play a critical role in addressing the growing antibiotic resistance threat.”

Cambridge, MA-based Spero is a biopharmaceutical company developing a pipeline of novel treatments for bacterial infections. The company’s pipeline of anti-infective agents is one of the most unique in the industry – focused on Gram-negative bacterial infections and Gram-positive and negative bacteria, fungi and protists.

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Indian firm developing vaccine for Zika virus

Feb 3, 2016 0

The mosquito-transmitted infection is related to Dengue, Yellow Fever and West Nile virus.

HYDERABAD– Hyderabad-based Bharat Biotech is developing world’s first vaccine for Zika virus, which has been declared as public health emergency by the World Health Organisation.

The vaccines and bio-therapeutic manufacturer on Wednesday announced that it is working on ZIKAVAC vaccines for Zika infection.

The company, which claims to be working on the vaccine for one-and-half years, has informed both the World Health Organisation (WHO) and the government of India about the status of its project.

Krishna Ella, chairman and managing director, Bharat Biotech, told reporters that the pre-clinical trials for the vaccine will start in a week or two.

The company has filed global patents for both inactivated and recombinant vaccines.

He said the company was ready to partner with Latin American countries like Brazil for the vaccine development. Some Latin American companies have already shown interest in partnering with it for human trials.

“It depends on the regulatory system in the country,” he said when asked how long it would take for the vaccine to hit the market in India. Ella said that if the government declares Zika as a national emergency and takes an aggressive stand, the vaccine can be developed in less than two years.

Sumathy, director, research and development, Bharat Biotech, who is heading the vaccine development, said they started the work on this along with the development of vaccine for Chikungunya but the work was progressing at a slow pace.

She said with the virus spreading fast to Latin America and the WHO declaring it public health emergency, they will now speed up the project.

The inactivated vaccine has reached the stage of pre-clinical testing in animals. The pre-clinical trials may take two to five months while human trials will take another four to five months.

Ella pointed out that Zika is now present in 23 countries. Brazil, the hardest-hit country, has reported around 3,530 cases of the devastating birth defect called microcephaly in 2015 that are strongly suspected to be related to Zika.

The Zika virus is spread by mosquitoes of the Aedes genus, which can breed in a pool of water as small as a bottle cap and usually bite during the day. The mosquito-transmitted infection is related to Dengue, Yellow Fever and West Nile virus.

Bharat Biotech has invested over $150 million since inception to build its portfolio of vaccines including ROTAVAC, the first vaccine from the developing world

It has successfully commercialised Typbar TCV, typhoid conjugate vaccine. Chikungunya Vaccine will be entering phase 1 trials shortly.

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Abbott to buy Sri Lankan-Born Namal Nawana’s Alere for $5.8 billion

Feb 1, 2016 0

WALTHAM, MA— Abbott and Alere Inc. announced today a definitive agreement for Abbott to acquire Alere, for $5.8 billion. Sri Lankan-born Namal Nawana serves as the Chief Executive Officer of Alere.

Namal Nawana

Namal Nawana

Under the terms of the agreement, Abbott will pay $56 per common share at a total expected equity value of $5.8 billion. Once the transaction is completed, Abbott will become the leading diagnostics provider of point of care testing. Abbott’s total diagnostics sales will exceed $7 billion after the close.

Nawana was born in Sri Lanka and raised in Australia. He holds an Honors degree in Mechanical Engineering and a Masters of Medical Science degree from the University of Adelaide in Australia and an MBA from the Henley Business School in the United Kingdom.

Nawana serves as CEO, president and a member of the Board of Directors of Alere. Since his appointment in 2014, Nawana has re-oriented the company to focus on its strengths, as the global leader in rapid diagnostics behind the new vision of Knowing now matters

Before joining Alere, Nawana held various global leadership roles during his 15-year tenure at Johnson & Johnson. He most recently served as Worldwide President of DePuy Synthes Spine, a Johnson & Johnson company. Prior to that role, Nawana held general management positions spanning the globe, including Area Vice President for Johnson & Johnson Medical in Australia and New Zealand and Chairman of the DePuy Asia Pacific Franchise Council.

“The combination of Alere and Abbott will create the world’s premier point of care testing business and significantly strengthen and grow Abbott’s diagnostics presence,” said Miles D. White, chairman and chief executive officer, Abbott. “We want to offer our customers the best and broadest diagnostics solutions. Alere helps us do that.”

Upon completion of the transaction, the combined business will offer the broadest point of care menu of infectious disease, molecular, cardiometabolic and toxicology testing, expanding Abbott’s platforms to include benchtop and rapid strip tests. Abbott will be able to better serve an expansive customer base around the world while also accelerating innovation in point of care diagnostics. More than half of Alere’s $2.5 billion in sales are in the U.S. Alere also has a growing presence in key international markets, where Abbott’s capabilities and infrastructure will drive accelerated growth of Alere’s portfolio.

“Today’s announcement marks an exciting and transformative milestone for Alere and one that provides an immediate benefit for our stockholders,” said Nawana. “Our leading platforms and global presence in point-of-care diagnostics, combined with Abbott’s broad portfolio of market-leading products, will accelerate our shared goal of improving patient care. I’d like to thank our global workforce of nearly 10,000 employees whose hard work and dedication has enabled Alere to contribute to improved patient outcomes throughout the world.”

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