Industry Blog

9
Jan 10

Use generic drugs instead of Branded saves costs.

In England there have been plans to increase the prescription of less expensive medicines in primary care.

They are eager to use the more generic medicines as they are less expensive than the branded ones. The proposition includes making a list of products for replacement, and another list of items that would be excused. They will put out for the publics opinion over the next 3 months.

 

The NHS spends about £9 billion a year, on branded medicines in the UK alone, and a 5 year voluntary contract negotiated between the government and pharmaceutical company last year includes dropping what the NHS spend on branded medicines.

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7
Jan 10

Sir Allen McCray Passes.

The news of Sir Allen McClay passing has saddened many, it has been said that McClay, 77, was the most successful business man ever produced in the pharmaceutical industry.

 

Leaving behind his wife, Heather in who he married last November in hospital.

McClay qualified as a pharmacist in 1953 and 15 years later he established his own company Galen in 1968.

 

Out of this company, he became a multi millionaire, as it was a world leading bio-tech and pharmaceutical company, this made him one of Irelands richest men.

 

Honours have been paid to Sir Allen by the NI deputy first minister, Martin McGuinness, and the chief executive of Almac.

 

Mr McGuinness said: “I know that I will echo the thoughts of many when I say that we have not only lost a wonderful businessman but also a true gentlemen”.

 

It’s a shame to see such a great man pass.

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4
Jan 10

Novartis to buy big stake in Alcon

A large swiss company called Novartis said yesterday that it would be taking control of Alcon, Eye Care Company by purchasing a majority stake from Nestle at the amount of $28.1 billion, raising its on to 77%, eventually they would also like to acquire the rest.

Collectively with the $10.4 billion paid by Novartis for it last year and nearly $11.3 billion of its own shares which is presenting minority shareholder for the final 23% of Alcon, it is set to be the biggest most expensive merger in Swiss History.

The company is approaching further into the eye care industry hoping to benefit from Alcons, Pharmaceutical, surgical and consumer eye care business lines which benefitted a $6.3 billion in 2008 sales alone.

Raymund Breu, chief financial officer of Novartis, said in an interview that the eye-care business had “higher growth rates than many other franchises in the health care sector’’ and that the market expected eye care to stay elevated for another five years.

“There is little overlap between the businesses,’’ said Eric Althoff, a spokesman for Novartis, explaining that he did not anticipate antitrust issues because Alcon was more concentrated in surgical treatments, and Novartis in pharmaceutical treatments and consumer products. Among Novartis’s more well-known eye products are GenTeal eye drops, Zaditen Ophtha for seasonal allergies, and Nyogel for ocular hypertension.

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2
Jan 10

MCI norms to clip ‘tourist’ docs’ wings

The medical council of India has banned the practitioners from being at events or seminars which are financed but Pharmaceutical Companies.

 “A medical practitioner shall not accept any travel facility inside the country or outside, including rail, air, ship, cruise tickets, paid vacations etc, from any pharmaceutical or allied healthcare industry or their representatives for self and family members for vacation or for attending conferences, seminars, workshops, etc,” reads the MCI (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2009. 

 During 2009, there were important medical events held which attracted 10,000 or more doctors, who came along with some of their family members, which ended in a big “tourist turnout”. 

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15
Nov 09

Top Five International Pharmaceutical Company Awards Comprehensive Cardiac Safety Study to iCardiac

iCardiac Technologies, Inc., a global leader in advanced cardiac core lab services and QT analysis, announced today that a top five pharmaceutical company has awarded iCardiac a comprehensive “Thorough QT” (TQT) study. iCardiac will provide end-to-end study management, international equipment deployment and scientific reporting, as well as advanced ECG analytics. The study will utilize iCardiac’s Highly Automated QT and Dynamic QT beat-to-beat(sm) service offerings to dramatically improve study precision and reduce false positives and negatives.

“iCardiac’s ability to reduce sample size as well as false positives in TQT studies continues to be well received by the pharmaceutical industry,” said Sasha Latypova, Executive Vice President. “As these methods are now accepted as part of the regulatory review of cardiac safety, we expect the speed of adoption to continue to accelerate.”

In October 2005, the FDA introduced a new guidance for industry (ICH E14) requiring the evaluation of pro-arrhythmic potential of new drugs by measuring the QT segment of ECGs collected in clinical trials. The dissatisfaction among pharmaceutical developers with the poor precision, high rate of false positives/negatives and high cost of the “gold standard” manual or semi-automated QT measurements has lead to efforts toward providing more advanced cardiac safety analytics.

Source: EARTH TIMES

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19
Oct 09

Transformative Times for BioSante Pharmaceuticals

The last 75 days have been transformative for BioSante,” Bill Milling, Sr. Dir Operations for BioSante Pharmaceuticals, Inc. (BPAX) told BioMedReports. Yesterday, the company announced positive safety data in its ongoing LibiGel Phase III clinical development program.

“First we closed a financing in August having raised $12 million,” explained Milling. “We then closed a merger on October 14 which brought in an additional $23 million and added a strong portfolio of cancer vaccines. Yesterday we reported very positive safety data in our LibiGel development program for the treatment of female sexual dysfunction. Overall, we now have enough cash to get through LibiGel clinical data and to an NDA.”

BioSante is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism and yesterday they reported that the DMC reviewed all unblinded adverse events in the safety study including all “serious adverse events” and all “adverse cardiovascular and breast cancer events” in 1,055 women with 883 women-years of exposure. To date, there have been no deaths, one myocardial infarction and only three breast cancers reported. Therefore, in view of the DMC recommendation, the BioSante LibiGel Phase III development program will continue as planned.

BioSante targets submission to the FDA of a new drug application (NDA) by mid-2011.

Last week, BioSante and Cell Genesys, Inc. (CEGE) announced the successful completion of their previously announced merger into BioSante, under which BioSante now has acquired all of the outstanding shares of Cell Genesys common stock. That deal was valued at $38 million.

BioSante Pharmaceuticals Inc. said Wednesday that it completed an all-stock buyout of Cell Genesys Inc. and the combined company will focus on developing a topical testosterone gel intended to treat sexual dysfunction in women, but it also plans to develop Cell Genesys’ cancer treatment GVAX. Cell Genesys, based in South San Francisco, Calif., was developing GVAX, as an immune treatment for prostate cancer, but discontinued testing last year after one trial was likely to fail and another had an unexpectedly high rate of patient deaths.

The company said GVAX is now being tested as a potential treatment for pancreatic cancer, leukemia and breast cancer.

BioSante also now owns a stake in Ceregene Inc., a former subsidiary of Cell Genesys, which is developing gene therapies for neurodegenerative disorders.

Several analysts are feeling bullish about the stock and feel it has good potential given it’s current Phrase III trial, cash reserves, latest safety news and the BioVant™ H1N1 adjuvant in their pipeline.

In August, BioSante announced that BioVant™, increased the protective effect of vaccines for multiple flu strains, including a potential new vaccine against H1N1 (swine flu), which resulted in 100 percent protection from symptoms of illness, including weight loss, and death in animal studies.

Source: http://seekingalpha.com

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27
Aug 09

Warner Chilcott buys rival pharmaceutical firm for £3bn

A Pharmaceutical giant with strong links to Northern Ireland is buying a global pharmaceuticals business for £3.1bn.

 

Warner Chilcott’s acquisition of Proctor & Gamble’s branded pharmaceutical products and other businesses is expected to be complete by the end of this year.

US-founded Warner Chilcott was acquired in 2000 by Craigavon-based Galen Holdings, which took the name of its new acquisition and was Northern Ireland’s first billion dollar company.

Warner Chilcott was taken over by US private equity investors in 2004 but former Galen Holdings chairman Dr John King remains a non-executive director.

Galen Holdings was founded by Sir Allen McClay from Cookstown in 1968.

Sir Allen, one of Ireland’s richest men, stepped down from Galen in 2001, and a year later set up pharmaceutical and biotech company Almac in Craigavon. It now employs over 2,000 people in Craigavon, the US and other parts of the UK.

Also included in Warner Chilcott’s deal with P&G are its prescription drug product pipeline and manufacturing facilities in Puerto Rico and Germany.

Most of P&G’s 2,300 pharmaceutical staff are expected to transfer to Warner Chilcott, which already employs over 1,000 people worldwide including 120 people in the manufacture of women’s healthcare treatments in Larne, Co Antrim.

Roger Boissonneault, president and chief executive officer of Warner Chilcott and a former chief of Galen, said: “The acquisition of the P&G pharmaceutical brands and employee talent is a transformational, strategic move for us.

“The acquisition transforms Warner Chilcott into a global pharmaceutical company, expands our presence in women’s healthcare, establishes us in the urology market in advance of the anticipated launch of our erectile dysfunction treatments, and adds gastroenterology therapies to our product portfolio.”

www.belfasttelegraph.co.uk

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