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Tr The Pharma Matters
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MOVERS AND SHAKERS
A PHARMA MATTERS REPORT.
July – September 2009
The Thomson Reuters quarterly report on the US generics
industry using strategic intelligence and competitive analysis
information from Newport Premium™, the critical product
targeting and global business development system from the
industry authority on the global generics market.
2. In this quarterly report, we look at a few of the companies
beginning to make their marks on the US generics market either
with their finished dose products or active ingredients, and
analyze trends and statistics relating to the market as a whole.
For more information on Thomson Reuters
API Intelligence solutions, including Newport Premium,
visit go.thomsonreuters.com/globalgenerics
PHARMA MATTERS | MOVERS AND SHAKERS
3. Section I: Introduction What is
an ANDA?
As the northern hemisphere heads toward winter, it fell to the
12th annual IGPA annual meeting, held in Montreal at the end An Abbreviated New
Drug Application
of September, to provide cheer and encouragement. Jim Keon,
(ANDA) is the first
the President of CGPA, reminded delegates that the generic step for a generic
industry is greatly benefiting from governments and other payers drug in the US. It
encouraging the use of generic drugs in order to reduce health is submitted to the
care expenditures. FDA to prove that
the generic version
The US pharmaceutical industry, including the generic sector, is bioequivalent to
could see a boost from the reforms that are currently being the innovator drug
discussed. According to Ben Sasse, Former US Assistant in question. On
approval, the generic
Secretary of Health & Human Services, the pharmaceutical version is added
industry has been supportive of the reform since it will likely see to the Approved
demand for its products go up significantly if millions of new Drug Products List
patients are insured. (“Orange Book”) and
the company may
According to Alan Sheppard, Principal of Global Generics, IMS manufacture and
Health, the global generic market is now worth $80 billion and is market it. An ANDA
experiencing 8% growth, up from 3% last year, though it is down may be submitted
before the patent on
from the double digit growth rates the industry saw in 2004–
the innovator drug
2007. In the US and UK, the growth of the generic industry is expires. However,
back in positive territory, a welcome finding after 2008, when the in that case, the
generic industries in these two countries experienced their first ANDA must include a
ever period of negative growth. The industry is growing at double certification indicating
that the filer does
digit rates in China (25%) and Brazil (12%).
not seek to market
For the first time ever, generics make up over half of the volume the product before
of total pharmaceutical sales in unit terms, though there the expiry of the
Orange Book-listed
continue to be dramatic differences in terms of market share in patents (“paragraph
key markets—ranging from over 60% in US and UK to less than III certification”) or
30% in Italy and Spain. that the filer believes
that its product
Upcoming patent expiries continue to offer significant does not infringe the
opportunities for generics in many major markets. In the US Orange Book-listed
alone, over $90 billion in brand sales is at risk from patent patents or that the
expiries taking place between 2009 and 2013. However, as Ken Orange Book-listed
patents are invalid
Cacciatore, Managing Director, Cowen and Company, warned,
(“paragraph IV
if generic opportunities are in undifferentiated products with no certification”).
sourcing, formulation or manufacturing challenges, then the
generic opportunity from those brand products will be minimal. What are “A”
rated drugs?
Several speakers raised the hope that biosimilars may be one of
“A” rated drugs
the growth opportunities for the generic industry, but seemed
are considered
quite skeptical that more than a few generic companies will have therapeutically
all the necessary capabilities to participate in the generic biologic equivalent and can
arena: biologic formulation capabilities, biologic manufacturing be substituted for
capabilities, experience with clinical trials, sales force capable of each other. “A” rated
drugs are designated
marketing the non-substitutable products, and sufficient capital
as AA, AB, AN, AO,
required for the investments. These capabilities are found within AP, and AT in the
large pharmaceutical companies and within the biotechnology Orange Book.
PHARMA MATTERS | MOVERS AND SHAKERS
4. industry, and therefore those companies might be more suited
What is a
US DMF? to participate in the generic biologic arena. Defensive price
reductions by originators could serve as additional barriers to
A DMF (Drug Master
File) is a confidential
generic biologics.
document As discussion continues, Movers & Shakers continues to show
covering a specific
significant activity throughout the US generics industry. First,
manufacturing
facility, process or
let’s take an in-depth look at this quarter’s ANDA approvals and
article used in the Paragraph IV challenges.
manufacturing,
processing, Section II: ANDA approvals
packaging or storing
of a bulk drug. A DMF
Total ‘A’-rated ANDAs by country of origin
is reviewed by the of applicant for July to September 2009
FDA only if an ANDA
or NDA referencing 122
that particular DMF
is filed. An ANDA
or NDA will not be
approved until any
issues with the DMF
are resolved.
What is the 180- 44
39
day exclusivity?
In order to encourage
generic companies 9 7 5 4 3 3 3
to develop non-
1 1 1 1 1
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and challenge invalid
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180 days of market During the third quarter of 2009, US-based companies were
exclusivity for the first
again in the first place in terms of final approvals, with 44
company to file an
ANDA with paragraph
approvals going to 24 different groups, up from 36 approvals
IV certification for a going to 22 groups in the second quarter. Just like the second
product. The FDA quarter, Indian companies were in second place with 39
may not approve approvals going to 13 groups followed by Israel (9 approvals
additional ANDAs for
going to 1 group), Germany (7 approvals going to 2 groups) and
a period of 180 days
commencing from
Switzerland (5 approvals going to one group).
the first commercial Groups based in Canada, Iceland, Japan, Jordan, England,
marketing of the
Netherlands, Taiwan, Italy, and Belgium also received final
first-to-file product.
In cases where more approvals in this quarter.
than one ANDA
with Paragraph IV
certification is filed
on the same day, the
period of exclusivity
may be shared.
PHARMA MATTERS | MOVERS AND SHAKERS
5. Groups with the most ‘A’-rated ANDA approvals
What is
for July to September 2009 Corporate
API Rating?
9
Corporate API Rating
8 is a proprietary
analytic by
Thomson Reuters
6 designed to indicate
how capable a
5 5 5 5 corporate group
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bulk materials to
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such as North
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During the third quarter of 2009, Teva of Israel received 9 ANDA products supplied.
They are still
approvals, putting the group on top of the list. Aurobindo (8
considered capable
ANDAs) and Sun (6 ANDAs), both of India, were in the second and of supplying
third places. regulated markets.
In comparison, during the second quarter of 2009, Novartis Potential future
(through its Sandoz subsidiary) of Switzerland was on top of the list The group has an
interest in supplying
with 8 approvals, followed by Teva of Israel (6 approvals), Zydus-
regulated markets,
Cadila of India (5 approvals), and Mylan of U.S. (5 approvals). but so far has no
known performance.
Section III: Paragraph IV challenges
Local
In the third quarter of 2009, we learned of first paragraph IV Locally focused
patent challenges on ten new active ingredients or combinations, only (non-regulated
down from 14 during the previous quarter. Among the product markets).
challenges posted by the FDA in this quarter were docetaxel Big Pharma
Large innovator
company.
PHARMA MATTERS | MOVERS AND SHAKERS
6. anhydrous—Sanofi Aventis’s blockbuster antineoplastic product
What is a
paragraph IV marketed in the US as Taxotere®—and efavirenz, a blockbuster
challenge? anti-HIV product marketed in the US by Bristol-Myers as Sustiva®.
Bioequivalent Groups with the most patent challenges
generic versions of
on record as of September 2009
drugs that are not
protected by patents
140
can be produced and
marketed in the US by
any company, subject
to FDA approval.
However, a generic
company may obtain
FDA approval before
patent expiry if it 68 66
certifies its product 53
does not infringe
40 37
the listed patents 32 30 27
or the patents are 25 25 23 22
invalid (paragraph IV 16 14
certification). Patent
holders may then sue
the ANDA filer for
patent infringement. If
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45 days, the FDA may
approve the ANDA at
Teva continued to be by far the most prolific filer of ANDAs with
any time. patent challenges. At the time of writing this report, we are
linking them to challenges on 140 products, up from 136 the
quarter before.
Mylan has remained in second place with links to patent
challenges on 68 different products, up from 65 the quarter
before, with Novartis closely behind with challenges on 66
products, up from 62 products the quarter before.
PHARMA MATTERS | MOVERS AND SHAKERS
7. Products first exposed to Paragraph IV challenges,
as reported by the FDA between July and September 2009
Active Ingredient: • At least one company has filed an ANDA with Paragraph IV
atovaquone certification for a generic version of Malarone (atovaquone and
and proguanil
hydrochloride
proguanil hydrochloride) tablets, 250mg/100mg:
Glenmark Generics.
Posted by FDA: • The Orange Book lists three unexpired patents covering
1 July 2009 Malarone tablets in the 250mg/100mg strength:
Brand name: US Patent 5,998,449, US Patent 6,166,046, and US Patent
Malarone® 6,291,488 concern the combination of atovaquone with
proguanil for the treatment of protozoal infections. The
NDA Holder: pediatric exclusivities associated with these patents will expire
GlaxoSmithKline
on May 25, 2014. In its suit against Glenmark, GlaxoSmithKline
alleges infringement of all three patents.
• At the time of the first ANDA submission for a generic version
of Malarone tablets in April 2009, several active DMFs for
each component of the combination were on file with the FDA.
Glenmark Generics holds an active DMF for atovaquone that it
submitted in October 2008.
Active Ingredient: • At least one company has filed an ANDA with Paragraph
dexmedetomidine IV certification for a generic version of Precedex
Posted by FDA:
(dexmedetomidine hydrochloride) injection: Sandoz.
3 August 2009 • The Orange Book lists three patents covering Precedex:
US Patent 4,910,214 is the US product patent for
Brand name:
Precedex® dexmedetomidine. It will expire on July 15, 2013. Orion is the
assignee and sole owner of the patent and Hospira is the
NDA Holder: exclusive licensee in the United States.
Hospira
US Patent 5,344,840 concerns the sedation of non-intubated
patients before or during surgical and other procedures. It will
expire on September 6, 2011.
US Patent 6,716,867 covers the use of dexmedetomidine for
intensive care unit sedation. It will expire on March 31, 2019.
Hospira and Orion are co-assignees of that patent and
share ownership.
In their suit against Sandoz, Hospira and Orion allege
infringement of US Patent 4,910,214 and US Patent 6,716,867.
• Cambridge Major Laboratories submitted a DMF for
dexmedetomidine HCl in March 2009.
PHARMA MATTERS | MOVERS AND SHAKERS
8. Active Ingredient: • At least one company has filed an ANDA with Paragraph
docetaxel IV certification for a generic version of Taxotere (docetaxel)
Posted by FDA:
injection: Sandoz. Apotex, Hospira, and Sun have filed 505(b)
21 September 2009 (2) NDAs with Paragraph IV certification for docetaxel products.
• The Orange Book lists five patents covering Taxotere:
Brand name:
Taxotere® US Patent 4,814,470 claims docetaxel generically and will
expire on May 14, 2010.
NDA Holder: US Patent 5,438,072 is a formulation patent expiring on
Sanofi-Aventis
November 22, 2013.
US Patent 5,698,582, US Patent 5,714,512, and US Patent
5,750,561 are formulation patents expiring on July 3, 2012.
The suit against Sandoz alleges infringement of US Patent
5,714,512, US Patent 5,750,561, and US Patent 5,438,072.
The suits against the 505(b)(2) NDA filers allege infringement
of US Patent 5,714,512 and US Patent 5,750,561.
• At the time the first ANDA with Paragraph IV certification was
submitted for a generic version of Taxotere, several companies
held active DMFs for docetaxel.
Active Ingredient: • At least one company has submitted an ANDA with Paragraph
efavirenz IV certification for a generic version of Sustiva (efavirenz)
Posted by FDA:
tablets: Mylan.
1 July 2009 • The Orange Book lists five patents covering Sustiva tablets.
US Patent 5,519,021 is the basic product patent for efavirenz. It
Brand name:
Sustiva® will expire on May 21, 2013.
US Patent 5,663,169 claims methods of inhibiting HIV reverse
NDA Holder: transcriptase. It will expire on September 2, 2014.
Bristol-Myers Squibb
US Patent 5,811,423 also claims methods of treating HIV
infection and AIDS. It will expire on August 7, 2012.
US Patent 6,639,071 is directed to a process for the
crystallization of a reverse transcriptase inhibitor. It will expire
on February 14, 2018.
US Patent 6,939,964 also concerns crystal forms of efavirenz. It
will expire on January 20, 2018.
The Mylan notification letter included a detailed statement
of the factual and legal basis for Paragraph IV certification
to US Patent 6,639,071 and US Patent 6,939,964. The BMS
suit against Mylan alleges infringement of only US Patent
6,673,372, which is not listed for Sustiva in the Orange Book.
The estimated expiry date for that patent is June 10, 2019.
• At the time the first ANDA with Paragraph IV certification for
a generic version of Sustiva tablets was submitted, several
companies held active DMFs for efavirenz, including Matrix (a
Mylan subsidiary).
PHARMA MATTERS | MOVERS AND SHAKERS
9. Active Ingredient: • At least one company has filed an ANDA with Paragraph IV
epinephrine certification for a generic version of EpiPen (epinephrine) Auto-
Posted by FDA:
Injector: Teva.
8 September 2009 • The Orange Book lists only one patent covering EpiPen
(epinephrine) Auto-Injector:
Brand name:
EpiPen® US Patent 7,449,012, entitled “Automatic Injector,” was issued
by the Patent and Trademark Office on November 11, 2008 and
NDA Holder: will expire on September 11, 2025.
Meridian Medical
• At the time Teva submitted its ANDA for a generic epinephrine
Technologies
injection product, Boehringer Ingelheim and Wockhardt held
active DMFs for epinephrine.
Active Ingredient: • At least two companies have filed ANDAs with Paragraph IV
fluvoxamine maleate certification for generic versions of Luvox CR (fluvoxamine
Posted by FDA:
maleate) extended-release capsules: Actavis and Anchen.
17 August 2009 • The Orange Book lists only one patent covering Luvox CR capsules:
US Patent 7,465,462 concerns multiparticulate controlled
Brand name:
Luvox CR® release selective serotonin reuptake inhibitor formulations and
will expire on May 10, 2020. Elan is the assignee of the patent
NDA Holder: Jazz and Jazz Pharmaceuticals is the exclusive licensee.
• At the time the first ANDA for a generic version of Luvox CR
capsules was filed in early 2009, several companies held DMFs
for fluvoxamine maleate, including Apotex, Medichem, Lonza,
TAPI Puerto Rico (Teva), and Sun. This is not surprising since
generic fluvoxamine maleate tablets have been approved in the
U.S. since 2000.
Active Ingredient: • At least one company has filed an ANDA with Paragraph IV
minoxidil certification for a generic version of Men’s Rogaine (minoxidil)
Posted by FDA:
topical aerosol foam: Perrigo.
17 August 2009 • The Orange Book lists only one patent covering Men’s Rogaine
topical aerosol foam:
Brand name:
Men’s Rogaine® US Patent 6,946,120 concerns a homogeneous aerosol
formulation consisting of approximately 5% or greater by
NDA Holder: weight of minoxidil or a pharmaceutically acceptable salt
Johnson & Johnson thereof. It will expire on April 20, 2019. Stiefel is the assignee
of the listed patent and Johnson & Johnson is the owner of the
approved NDA.
• At the time the first ANDA a generic version of Men’s Rogaine
topical aerosol foam was filed in early 2009, active DMFs for
minoxidil were held by Alchymars, Flamma, Kumar Organic
Products, and Solmag.
PHARMA MATTERS | MOVERS AND SHAKERS
10. Active Ingredient: • According to Wyeth, at least five companies have filed ANDAs
piperacillin sodium with Paragraph IV certification for generic versions of Zosyn
and tazobactam
sodium
(piperacillin sodium/tazobactam sodium) for injection. Orchid’s
ANDA for a generic version of Zosyn for injection included
Posted by FDA: Paragraph IV certification. Sandoz and Abraxis have also
21 September 2009 filed ANDAs for the piperacillin/tazobactam combination; we
assume those ANDAs also included Paragraph IV certification.
Brand name:
Zosyn® • The Orange Book lists only one patent covering Zosyn for injection:
US Patent 6,900,184 concerns compositions containing
NDA Holder: piperacillin and tazobactam in the presence of a buffer,
Wyeth
preferably citrate, and a particulate formation inhibitor,
preferably EDTA. It will expire on April 14, 2023. According to
the Orange Book, the patent includes both drug substance and
drug product claims related to Zosyn for injection.
• Aurobindo, Orchid, Sandoz, and Shandong Qilu King-Phar
are among the holders of active DMFs for both components
of the combination.
Active Ingredient: • At least two companies have filed ANDAs with Paragraph IV
repaglinide certification for generic versions of PrandiMet (repaglinide/
and metformin
hydrochloride
metformin HCl) tablets: Actavis and Sandoz.
• The Orange Book lists only one unexpired patent for
Posted by FDA: PrandiMet tablets:
21 September 2009
US Patent 6,677,358 concerns the fixed combination or
Brand name: simultaneous administration of repaglinide with metformin to
PrandiMet™ lower blood glucose and includes both use and formulation
claims. It will expire on June 12, 2018.
NDA Holder:
Novo Nordisk Novo Nordisk alleged infringement of US Patent 6,677,358 in
suits against Caraco and Mylan concerning ANDAs for generic
versions of Prandin (repaglinide) tablets.
Active Ingredient: • At least one company has filed an ANDA with Paragraph
solifenacin succinate IV certification for a generic version of Vesicare (solifenacin
Posted by FDA: 3
succinate) tablets: Teva.
August 2009 • The Orange Book lists only one patent covering Vesicare tablets:
US Patent 6,017,927 includes both drug substance claims and
Brand name:
Vesicare® drug product claims. It will expire on November 19, 2018.
• At the time of the first ANDA submission for a generic version
NDA Holder: of Vesicare tablets, Teva held a DMF for solifenacin and Dr.
Astellas
Reddy’s Laboratories and Glenmark Generics held DMFs for
solifenacin succinate.
PHARMA MATTERS | MOVERS AND SHAKERS
11. Section IV: Notable deals
Much of the deal-making in the generic industry remains around
biologics and emerging markets.
Sanofi-Aventis continued its aggressive program of acquisitions
in the third quarter, after gathering the Mexican generic
manufacturer Laboratorios Kendrick and the Brazilian drug
company Medley during the first half of the year. In July 2009
it announced two further deals. Firstly, it will acquire the Indian
biologics and vaccines manufacturer Shantha Biotechnics for
$784 million through its vaccine division Sanofi-Pasteur. Shantha
Biotechnics is expected to command sales of $90 million this year.
Secondly, it will buy the Swiss generics company Helvepharm,
which has an expected turnover of $29 million this year.
In July Valeant Pharmaceuticals International acquired the Mexican
generic manufacturer Tecnofarma S.A. de C.V. The deal gives
Valeant two new capabilities in Mexico: to exploit Tecnofarma’s
sales experience to the Mexican Government and private labels,
and to reduce its dependence on third party manufacturers due to
Tecnofarma’s 160,000 square foot manufacturing plant. Tecnofarma
boasts a portfolio of 80 registered products and commands sales of
approximately $33 million.
Section V: Opening moves
Based on our research of ANDA filings and Paragraph IV
challenges, we highlight some of the companies making
significant game play in the US generics industry.
Alembic Ltd
Alembic received its first ANDA approval in January 2009.
So far this year, Alembic Ltd has received final approvals
for five drugs (famotidine, fluoxetine hydrochloride, lithium
carbonate, meprobamate and metronidazole). In the third
quarter, it received a tentative approval for a sixth, pramipexole
dihydrochloride. In 2007, the company reported that it was
expecting to file new ANDAs at the rate of 12-15 per year for the
subsequent three years.
Though a newcomer to the US generic market, the company is
certainly well established as a finished dose and API manufacturer
in India, with a 3 million square meter manufacturing facility in
Baroda, numerous ISO and WHO certifications, and a history
stretching back more than a hundred years. It specializes in
antibiotics and other fermentation products, which it exports to
more than 70 countries around the world.
Alembic is also investing in new drug delivery systems. In 2007,
the company signed a licensing deal with UCB to apply Alembic’s
novel drug delivery system for a once-a-day version of UCB’s
Keppra® (levetiracetam).
PHARMA MATTERS | MOVERS AND SHAKERS
12. Tris Pharma
This New Jersey specialty pharmaceutical delivery company is
notable as a new player in the US generic market. It has one
new patent challenge (for cough medicine dextromethorphan
polistirex, tradename Delsym®) and one ANDA (for ibuprofen
suspension/drops) approved on 31 August 2009.
It may be new in the generic sphere, but Tris Pharma boasts a
pipeline of over 50 products in active development and a number
of proprietary technologies including Controlled Release,
Enhanced Solubility/Bioavailability, Fast Dissolve/ODT, and
Abuse Deterrence. Its OralXR platform pioneered the sustained
release delivery of drugs through liquid, chewable tablet, and
other forms, suitable for patients who cannot swallow pills.
Tris Pharma has also licensed its technology to other companies.
Four years ago, it entered into technology licensing and product
development agreements with Interpharm Holdings (acquired
in 2008 by Amneal) covering the development of 25 liquid
products and seven solid oral dosage products. In 2007, Tris
Pharma licensed its LiquiXR technology, a novel and propiretyar
drug delivery platform for sustained relase products in liquid
form, to Alpharma.
MDRNA Inc
Based in Bothell, Washington state, biotechnology company
MDRNA Inc (formerly Nastech Pharmaceutical) holds an approved
ANDA for the osteoporosis treatment salcatonin (aka calcitonin-
salmon) nasal spray, marketed by Novartis as Miacalcin®.
Although the ANDA included Paragraph IV certification, Novartis
elected not to sue because the application was based on a
different formulation. On April 1, 2009, MDRNA announced an
agreement with Par Pharmaceutical, Inc. under which Par would
acquire a manufacturing facility and MDRNA’s salcatonin ANDA.
In return, MDRNA would receive an upfront payment and double-
digit profit sharing on commercial sales of salcatonin. The FDA
approved the ANDA on June 8, 2009, and Par announced that it
had begun shipping the product the next day.
MDRNA hopes the revenue generated from salcatonin will
provide it with working capital to advance its core research, the
development and commercialization of therapeutic products
based on RNA interference (RNAi), primarily for oncology and for
hepatocellular carcinoma and other liver diseases.
PHARMA MATTERS | MOVERS AND SHAKERS
13. Image Copyright: Thomson Reuters
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