Pharmaceutical News

Abon Pharmaceuticals announces its presence; Stada sells Russian plants

An interesting article from Espicom’s  World Generic Markets business publication.

On 31st July 2012, Abon Pharmaceuticals announced that it had filed an ANDA with a Paragraph IV certification with the FDA for a proposed generic 1 mg / ml clofarabine injection product.  The proposed generic is a version of Genzyme’s Clolar Injection, a prescription drug indicated for the treatment of paediatric patients between one and 21 years old with relapsed or refractory acute lymphoblastic leukaemia.  The filing has led to Genzyme filing a lawsuit against Abon in the US District Court for the District of New Jersey, alleging infringement of patent number 5,661,136, the only patent listed in the FDA’s Orange Book protecting Clolar, and which expires on 14th January 2018, but additional paediatric exclusivity until 14th July 2018.  To date, no versions of Clolar, which was introduced in the US in December 2004, have been tentatively or fully approved by the FDA.

Abon Pharmaceuticals is a new company, having been founded in 2009, and is based in Northvale, New Jersey.  This patent challenge announcement appears to herald the firm’s first generic; Abon has commented that the filing is an important milestone for it.  The firm describes itself as a specialty pharmaceutical company engaged in the development of generic and proprietary products that have challenging formulation barriers.  The firm has filed a number of patent applications for drug delivery technologies.  Abon was founded by two former employees of Barr Pharmaceuticals: Salah U Ahmed and Bruce Downey.  In Barr, Dr Ahmed had been the Executive Vice President of Global Research and Development and Chief Scientific Officer, and had been responsible for the development of generic and proprietary pharmaceuticals as well as API and biotechnology products.  Dr Ahmed worked with Barr for 16 years.  Bruce Downey had been the Chairman and CEO of Barr, and had joined the firm in 1993.  Unlike Dr Ahmed, Mr Downey had a law background prior to joining Barr.

Elsewhere, on 7th August 2012, Stada Arzneimittel announced that it expected the sale of two Russian production facilities to occur within the third quarter of 2012, further announcing on 15th August that the contract for the sale had been signed.  The facilities are being sold through a partial management buyout; the assets of the facilities have been transferred through the sale of Stada’s indirectly-owned subsidiaries, OOO Makiz Pharma and OOO Skopin Pharmaceutical Plant, to LLC DMN Invest Moscow.  Stada commented that the sale of the plants fit in with its Group-wide cost efficiency programme, which was announced in 2010.  All products currently manufactured for Stada in the plants will be transferred to other existing Russian Stada facilities, in a move expected to be finalised in 2014.

Russia is Stada’s second-largest market, behind Germany.  In 2011, the firm reported sales in Russia worth 279.6 million euros (US$389.4 million), compared to 479.9 million euros (US$668.4 million) in Germany.  Sales in Russia in 2011 grew by some 26% in euro terms over 2010.

Article source: Ian Platts. Editor of Espicom’s business publication World Generic Markets

For more information on Espicom or any Generic Market products visit www.espicom.com

The latest conference news from Espicom.

Metabolic Disease Drug Development

Strategies for optimizing pharmaceutical performance in obesity, diabetes and dyslipidemia

23 – 25 October 2012 | Boston, MA

www.metabolicdisease-drugdev.com

Born out of the continuing unmet medical need, bottlenecks in the pipeline and a harsh regulatory climate, this meeting is only commercially focused event in the field. The agenda and networking opportunities have been crafted to help you identify where the innovation will come from in your metabolic drug pipeline and learn what clinical strategies will satisfy regulators.

By guaranteeing direct access to the most experienced and influential minds from industry and academia in the metabolic disease sector, it provides the perfect platform on which to direct your near and long term development strategy.

What to expect this year:

• Expert insight into the very latest clinical strategies to speed passage of metabolic drugs to market
• Candid discussion with Pfizer, Merck and Daiichi Sankyo among others on innovation and differentiation in the field of metabolic drugs
• Excellent opportunities to network with the most innovative biotechs and influential pharma companies in the metabolic disease space

Addressing the most pressing technical and strategic issues in the metabolic disease sector will be 24 experts in the field, including…

• Vincent Mascitti, Senior Director, Global R&D, Pfizer
• Sethu Reddy, VP, Head of US Medical Affairs, Merck
• Michael Mark, VP, Cardiometabolic Diseases Research, Boehringer-Ingelheim
• Steven Smith, Scientific Director, Sanford-Burnham Institute
• Thomas Strack, VP, R&D, Diabetes and Metabolic Disease, Takeda

To see the full speaker panel and exactly what they will be sharing, visit the website or download the brochure.

There are a limited number of priority registration places available with savings of up to 400 USD.  To register, simply:

Call: + 1 212 537 5898

Email: register@hansonwade.com

Visit: www.metabolicdisease-drugdev.com/register

Remember to quote your priority booking code ESPICOM

www.metabolicdisease-drugdev.com

View Agenda | Packages & Prices | Register Now

Business Monitor International strengthens its pharmaceutical and medtech portfolio with acquisition of Espicom Business Intelligence

Business Monitor International, leading provider of country risk, financial markets and industry research across global markets, has announced the acquisition of Espicom Business Intelligence in a move which signals BMI’s continuing commitment to deepening its presence in key market sectors.

London, UK, August 21 2012 – Business Monitor International (“BMI”) has announced the acquisition of Espicom Business Intelligence (“Espicom”), a UK-based company with a 30-year pedigree providing business intelligence on Medical Devices, Pharmaceuticals & Healthcare and Therapeutics across global markets.  The acquisition reflects BMI’s commitment to deepening its market coverage of more than 20 industry verticals with specialist product and company intelligence. The financial terms of the transaction have not been disclosed.

The acquisition brings to BMI Espicom’s wide-range of information and business intelligence services for the global healthcare industries. In medical technology and devices, Espicom’s service features coverage of key operators in 70 country markets, proprietary 5-year forecasts, daily news on key technologies and critical management reports on areas such as advanced wound care, diagnostic products and market access. In pharmaceuticals, Espicom’s service features country-level data, therapeutics, generics and biosimilars markets coverage and specialized drug development database services.

BMI co-CEO Jonathan Feroze commented that “Espicom’s product and company level content, combined with BMI’s existing pharmaceuticals and healthcare coverage across 97 countries, will produce a holistic, market-leading offering”. Co-CEO Richard Londesborough added that “the acquisition of Espicom deepens our content portfolio in a highly strategic growth segment for BMI”.

Espicom founder and CEO Eric Wigart, added that “BMI is the ideal platform for bringing Espicom’s content to a wider audience.  Leveraging BMI’s global research, sales and account management capabilities will be a win-win for both companies”.

About Business Monitor International

Head-quartered in London, Business Monitor International (“BMI”) provides multinational corporations, financial institutions and government with integrated country risk, financial markets and industry research across 170 country markets and more than 20 industry verticals, with unrivalled coverage of emerging and frontier markets. Business Monitor Online, the company’s flagship online subscription service, features timely analysis, proprietary forecasts and risk ratings and rankings. Backed since 2009 by Spectrum Equity Investors, BMI has achieved rapid organic growth over the last decade, and now counts more than 400 of the Fortune Global 500 among its clients.

ENDS

Contacts

Matthew Brooks

Business Monitor International

·         mbrooks@businessmonitor.com

·         Tel: +44 (0)207 246 5117

Nigel Chivers

Espicom Business Intelligence

·         nigel_chivers@espicom.com

·         Tel: +44 (0)7793 211899

The newest version of The World Pharmaceutical Fact Book 2012 is now available!

Puts thousands of key pharmaceutical market statistics and trends at your fingertips!

In these challenging economic times the need to understand world pharmaceutical markets and be able to answer quickly those questions that arise daily is essential.  That is why an authoritative, current and comprehensive market intelligence and statistics source is an invaluable aid for every industry executive.  And that source is the best-selling The World Pharmaceutical Markets Fact Book.

Completely revised and updated for 2012, this highly-detailed market-leading business reference draws from a vast range of primary national/international government and commercial sources to provide a comprehensive range of hard-to-find business information on the markets for pharmaceuticals worldwide.

THE NEW, IMPROVED AND EXPANDED 2012 FACT BOOK BRINGS THE WORLD TO YOUR DESK, WITH:

• Comprehensive coverage of 66 markets around the world
• Five years (2006-2011) data and trend analysis for key market indicators

- Demography (eg population, growth, life expectancy)
- Economic (eg health expenditure)
- Healthcare infrastructure and personnel (eg hospitals, beds, surgical procedures)

• Rankings and overview for the world and 5 major regions
• Individual country statistics
• Over 500 tables and charts

AN EXCELLENT NEW BENEFIT: ALL CUSTOMERS CAN ACCESS THE FACT FILE IN ESPICOM INTERACTIVE

The Fact Book is rich in tables and charts, and with Espicom Interactive online you can access and use this key data easily.  All tables can be instantly exported to MS Excel™ and charts to MS PowerPoint™ while the fast search quickly pinpoints the data you need.  Best of all, Espicom Interactive is included in the report’s price!

THE FACT BOOK ANSWERS KEY BUSINESS QUESTIONS, SUCH AS…

• Which country spends most on pharmaceuticals as a % of GDP?
• How are the economic downturn and currency fluctuations affecting key markets?
• Which markets are growing the fastest?
• How does the Brazilian market compare with China and India in terms of total health expenditure?
• What demographic development is affecting the market in Central and Eastern Europe?
• What have been the key trends affecting pharmaceutical companies in leading Latin American Markets?

ORDER YOUR COPY TODAY

You can buy your copy of the 2012 Fact Book now.  For further information on the report’s extensive contents, please click here.  Please note that prepayment is not required on this report.

For more information or to see all the latest reports from Espicom, visit www.espicom.com

EC takes ‘pay for delay’ action against branded and generic firms

An interesting article from Espicom’s  World Generic Markets business publication.

On 25th July 2012, the European Commission reported that it had issued a Statement of Objections to Lundbeck, and on 30th July reported a similar Statement of Objections had been sent to Servier.  The statement to Lundbeck was also addressed to Merck KGaA, Generics (UK), Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma, AL Industrier and Ranbaxy Laboratories, and concerned possible ‘pay for delay’ agreements with regard to generic versions of citalopram.  The Servier statement regarded a possible pay for delay agreement with Niche / Unichem, Matrix Laboratories, Teva Pharmaceutical Industries, Krka and Lupin, and was with regard to generic competition for perindopril.

The actions have their roots in an EC investigation into the pharmaceutical sector which was begun in January 2008 to examine reasons why fewer new medicines were brought to market and why generic entry seemed to be delayed in some cases.  The final report was issued in July 2009, and found that market entry of generics had indeed been delayed.  The report suggested that company practices were amongst the reasons, leading to the EC announcing it would increase its scrutiny of the pharmaceutical sector, including monitoring settlements between originator and generic drug companies.  The Commission warned that agreements that delayed generic entry would be subject to competition scrutiny if used in an anticompetitive way.  The Statements of Objections issued in July are the latest part of the investigation.

Announcing the actions, Joaquin Almunia, Vice President of the European Commission responsible for Competition Policy, commented that the pharmaceutical sector was one in which the EC could not afford to tolerate any breach of competition rules.  Mr Almunia added that the companies involved would have rights of defence and an opportunity to reply to the objections; Lundbeck was quick off the mark to say that it disagreed with the findings.  However, whilst the EC may like to give the impression of close vigilance leading to swift action, inevitably, the wheels of bureaucracy do not run so smoothly.

Opening its formal investigation

The EC announced it was opening its formal investigation into Lundbeck in January 2010, stressing at the time that the investigation did not mean that the Commission had proof of infringements of competition rules: an action that was announced two years after the pharmaceutical sector inquiry opened, and would take another 18 months to reach the stage of a Statement of Objections.  The road ahead from here is likely to be equally long; Lundbeck noted that a Statement of Objections did not represent the EC’s final decision, adding that any final decision is appealable to the European Courts, with the whole process likely to take several years.

The Statements of Objections dovetailed with news of the EC’s 3rd report on its monitoring of patent settlements, one of the results of the pharmaceutical sector inquiry.  The report found that the number of potentially suspect settlements had stabilised, falling from 21% of all settlements in prior reports to 11%.  At the same time, however, the total annual number of concluded settlements had increased by 500%, from 24 settlements to 120, with most of these appearing to give no cause for alarm from an antitrust standpoint.  The EC commented that this showed that its increased vigilance was not hindering companies from entering into agreement, and speculated that in fact the vigilance may have made companies more aware of competition law issues, thus leading to more agreements passing inspection.  Thus the EC concluded that it was right to remain vigilant, and would continue its monitoring efforts.

The ongoing investigations regarding Lundbeck and Servier are not the only cases being investigated by the EC.  Other investigations are ongoing against Johnson & Johnson, Novartis and its generic firm, Sandoz, regarding fentanyl; and Teva and Cephalon regarding modafinil were opened in 2011, and are ongoing.  In addition, the EC noted that in July 2010, the EU General Court upheld the Commission’s decision in another case, against AstraZeneca, which was the EC’s first decision finding an abuse of dominant market position in the pharmaceutical sector.  AstraZeneca has appealed the decision to the EU Court of Justice.  However slowly the European cases may be going, it is interesting to compare the EC’s battle with the US Federal Trade Commission.

The EC General Court has agreed with the EC thus far, which would certainly give the Commission confidence, both with regard to pursuing individual cases, and in changing the environment in which settlement agreements are made.  In the US, the FTC has been less successful, with the courts generally disagreeing with the Commission over whether or not pay for delay agreements are anticompetitive, and the FTC’s monitoring of settlements has shown questionably anticompetitive agreements have remained consistent in recent years, and at a higher level than at any point since the FTC began collecting information in 2003.  The FTC may be starting to see some courts come round to its point of view, with an appeals court agreeing with the FTC in a recent ruling, but it is certainly a long road ahead for the FTC, which will almost certainly require Supreme Court and Congressional interventions.

Article source: Ian Platts. Editor of Espicom’s business publication World Generic Markets

For more information on Espicom or any Generic Market products visit www.espicom.com

Metabolic Disease Drug Development

Strategies for optimizing pharmaceutical performance in obesity, diabetes and dyslipidemia

23 – 25 October 2012 – Boston, MA

Born out of the continuing unmet medical need, bottlenecks in the pipeline and a harsh regulatory climate, this meeting is only commercially focused event in the field. The agenda and networking opportunities have been crafted to help you identify where the innovation will come from in your metabolic drug pipeline and learn what clinical strategies will satisfy regulators.

By guaranteeing direct access to the most experienced and influential minds from industry and academia in the metabolic disease sector, it provides the perfect platform on which to direct your near and long term development strategy.

What to expect this year:

• Expert insight into the very latest clinical strategies to speed passage of metabolic drugs to market.
• Candid discussion with Pfizer, Merck and Daiichi Sankyo among others on innovation and differentiation in the field of metabolic drugs.
• Excellent opportunities to network with the most innovative biotechs and influential pharma companies in the metabolic disease space.

Addressing the most pressing technical and strategic issues in the metabolic disease sector will be 24 experts in the field, including…

• Vincent Mascitti, Senior Director, Global R&D, Pfizer
• Sethu Reddy, VP, Head of US Medical Affairs, Merck
• Michael Mark, VP, Cardiometabolic Diseases Research, Boehringer-Ingelheim
• Steven Smith, Scientific Director, Sanford-Burnham Institute
• Thomas Strack, VP, R&D, Diabetes and Metabolic Disease, Takeda

To see the full speaker panel and exactly what they will be sharing, visit the website or download the brochure.

There are a limited number of priority registration places available with savings of up to 400 US$. To secure these rates you need to book your place before Friday 27th July. To register, simply:

Call: + 1 212 537 5898 or Email: register@hansonwade.com

Visit: www.metabolicdisease-drugdev.com/register for more details.          

——————————————————————————————–

Remember to quote your priority booking code ESPICOM

www.metabolicdisease-drugdev.com

View Agenda | Packages & Prices | Register Now

First generic nevirapine products approved by FDA

An interesting article from Espicom’s  World Generic Markets business publication.

On 22nd May 2012, the FDA granted final approval for ANDAs from a number of companies, including Apotex, Aurobindo Pharma, Cipla, Hetero Labs, Micro Labs, Mylan Laboratories, Mylan Pharmaceuticals, Prinston, Sciegen Pharmaceutical and Strides Arcolab for their respective generic 200 mg nevirapine tablets.  In addition, Aurobindo was also granted final approval for a second ANDA for 50 mg / ml nevirapine oral solution.  The products are generic equivalents of Boehringer Ingelheim’s Viramune, an antiretroviral used in the treatment of HIV/AIDS.  Viramune tablets and oral solution had been protected by one patent listed in the FDA’s Orange Book: patent number 5,366,972, which expired on 22nd November 2011, but had additional paediatric exclusivity until 22nd May 2012.

Commenting on the approval, Aurobindo Pharma noted that the products had a market size in the US worth some US$125 million for the year ended December 2011, according to IMS data.  Mylan added that IMS figures showed the market size for the 200 mg tablets to have been worth around US$116.6 million for the same time period.

In response to the approvals, Roxane Laboratories also reported on 22nd May that it had launched its 200 mg nevirapine tablets and 50 mg / 5 ml nevirapine oral suspension.  The products are authorised generic versions of Viramune tablets and oral suspension.  Roxane commented that its tablets are available in 200 mg bottles of 60, whilst the oral suspension is available in a 240 ml bottle.

Boehringer Ingelheim also marketed a 400 mg extended-release tablet nevirapine, under the brand name Viramune XR.  As yet, there are no generic equivalents approved in the US, although this version is also only protected by the ‘972 patent listed in the Orange Book.  However, this version also has new dosage form data exclusivity until 25th March 2014.  Viramune XR did not gain FDA approval until 25th March 2011.

Article source: Ian Platts. Editor of Espicom’s business publication World Generic Markets

WTG Introduces a Leading Early Drug Development Summit

With its 15 years conference production and management experience, WTG introduces a leading pharma event “Early Drug Development Summit” in December 3rd-4th 2012 at the Hotel Palace Berlin, Germany.

The Early Drug Development Summit brings early drug developers together to discuss maximising drug investments, toxicology, safety and biomarkers.

As a Drug Delivery Intelligence reader, you are entitled to our exclusive £300 discount of the full VIP Delegate Package. Book your place at the Early Drug Development Summit 2012 for only £1,195* at www.eddsummit.com/offer

We’re pleased to announce that Dr. Lucette Doessegger, Global Head of Translational Safety Medicine at Roche Switzerland, will be sharing her 10 years of industry experience on early drug development at the Early Drug Development Summit on Day 2, 4th December 2012 at 09:15 – 10:00 in Hotel Palace Berlin, Germany.

Dr. Doessegger will discuss “Using Translational Medicines in Early Drug Development”, which will cover:

• Designing risk management protocols to understand the mechanism of action and implement safety measurements.
• Using translational safety medicine to measure signalling before it reaches clinical trials.
• Efficiently determining the impact of toxicity effects on specific populations.

Confirmed speakers and their presentations include:

• Dr Andy Parsons, VP Preclinical Development, GSK UK Developing Business Frameworks for the Successful Co-creation of Value.
• Peter Theil, Head of Early Development PKPD, UCB Belgium Pre-IND PK/PD Characterization of Small Molecule Drugs and Biotherapeutics to Increase the Probability of Success of Drug Development.
• Stefan Proniuk, VP Development, Arno Therapeutics US Reducing development timelines to bring products to market faster.
• Ian Wilson, Senior Principal Scientist, AstraZeneca UK Successfully Identifying Human Drug Metabolites for Toxicity Testing.
• Frederik Deroose, Director, Global Business Office Integrator, Jansenn Belgium Successfully Using Virtual Outsourcing for Early Drug Development.
• Prof Jürgen Borlack, Head of Toxicology, Hannover University Germany Utilising Better Animal Models to Improve Safety Studies.

Visit the website www.eddsummit.com to look at the full programme and speaker list.

The two day conference offers pre-arranged one-to-one meetings between +30 pharma industry solution providers and +120 drug development experts as well as real life case studies from leading drug development companies; Roche, GSK, AstraZeneca, UCB and more.

For more information, visit www.eddsummit.com or contact Michaela Melcher Michaela.melcher@wtgevents.com or call +44 (0) 207 202 7690.

About WTG: www.worldtradegroup.com World Trade Group (WTG) is a leading global integrated media company. Operating within the sectors of HR, energy, pharmaceutical, food and beverage, manufacturing and supply chain, we organise and run some of the leading annual business events, bringing together senior executives from world class organisations.

*This offer is only available to end-users. If you are a consultant or solution provider please call us on +44(0)20 7202 7690 for our commercial opportunities.

The Drug Delivery & Formulation Summit Asia 2012

“The growth of drug delivery solutions is of increasing importance to pharmaceutical companies, and has resulted in significant changes in the drug delivery landscape.” *

The Drug Delivery & Formulation Summit Asia will welcome you at the Ritz-Carlton in Singapore on 17th – 18th October 2012.

Do not forget to claim your unique offer of only $995 if you confirm your participation before Friday, 20th July 2012. Join your colleagues at www.ddfsummitasia.com/offer

This annual networking summit will feature the exclusive presentation of Jack Aurora, CSO, Hisun Pharma on deploying advanced drug delivery systems in development.

Highlights of Jack Aurora’s presentation will include:

• Utilizing advanced delivery systems in taking a branded/generic drug to the next therapeutic level
• Balancing technological advancements with price considerations in delivery style selection
• Utilizing sourced technologies to overcome the weaknesses of branded drug delivery
• Controlled release systems in advancing lifecycle management strategies
• Partnering with speciality delivery companies in streamlining development

View the full program http://ddfsummitasia.com/program

Claim your exclusive discount – book before 20th July 2012 and pay only $995 *, saving you $600. Register your place at www.ddfsummitasia.com/offer

Read more about the confirmed speakers http://ddfsummitasia.com/speaker-faculty/

For group attendance or if you have any questions contact us on enquire@wtgevents.com. Alternatively you can call us in Singapore on +65 6521 2941 or in the UK +44(0)20 7202 7690.

* BioSpectrum, 16 May 2012
** This offer is only open to senior heads of drug development, formulation & delivery from pharmaceutical industries. For commercial opportunities please send an email to enquire@wtgevents.com

Advertised on behalf of Espicom Ltd

Understanding Russia’s Regional Health Markets

The fourth in a series of reports by Espicom, the new highly-detailed June 2012 Understanding Russia’s Regional Health Markets report provides a really in-depth examination of national and regional health economies throughout Russia.  In over 350 pages this new report provides an unparalleled source of granular data which readily allows the identification of opportunity and risk within the local health economy.

With this report you will know

• How is the population and wealth regionally distributed?
• Which provinces produce the highest levels of GDP?
• To what degree does Moscow skew analysis of Russia’s financial and health infrastructure?
• What is the primary and secondary health infrastructure in each region?
• How is healthcare delivered?
• What is the changing role played by private health provision?
• Which regions are better provided for and which still need investment?

Rich in statistics, charts and maps, this valuable report Understanding Russia’s Regional Health Markets takes you further into understanding the regional health sector.  A comprehensive introduction sets the national scene while summary data for each state/territory highlights the key economic characteristics and health infrastructure.  Comparative statistics are provided for each province and can be seen in the light of regional/national averages.

Cost-effective and practical – with machine translation into Russian
Understanding Russia’s Regional Health Markets costs just £395/€495/US$690 inclusive of pdf/print formats and Espicom Interactive.  This report is rich in charts and tables and Espicom Interactive’s “one click” extraction of data to MS Excel™ and MS PowerPoint™ means you can easily build the data into your own reports and information systems.  Text can also be machine translated into 9 different languages – including Russian.

For more information regarding this report visit www.espicom.com/rrm

If you have any questions please do not hesitate to call +44 (0)1243 756027.

Andy Crofts
Senior Researcher and Report Author

Other titles from this series include:

Understanding India’s Regional Health Markets
Understanding China’s Regional Health Markets
Understanding South Korea’s Regional Health Markets