Ranbaxy reported a net loss for the fourth quarter due to recalling its generic version of Lipitor in the US. Pharma exports from India are projected to reach Rs. 75,000 crore in 2012-13, a 25% increase from the previous year. The DIPP is seeking details from the Health Ministry on three expensive cancer drugs to determine if compulsory licenses could make them more affordable in India.

2. Ranbaxy restarts generic
Lipitor production
Reports stated that the company had recalled
Atorvastatin for select batches in the strengths
of 10 mg, 20 mg and 40 mg tablets from the US
market due to presence of foreign particles.

3. Conti...
Ranbaxy reported a consolidated net loss
of Rs 492 crore for the fourth quarter
ended December 31, mainly due to its
voluntary recall of Atorvastatin calcium
tablets from the US.

4. Pharmexcil projects Rs 75,000 cr
mark for Pharma exports
Pharma exports from Indian players for 2012-13 might
touch the Rs 75,000 crore mark. This shall account for
a hike by 25 per cent from last year.
The pharma export level stood at Rs 17,000 crore for
2004. This is sharp contrast against the 2012 figures
of Rs 63,000 crore.
The countries that see maximum exports from India
are USA( 27%), Europe (19%), Africa (17%), the
Middle East (7%), Latin America( 6%) and the
Commonwealth of Independent States (CIS)
Countries(5%).

5. Conti....
In 2010, the Commerce Ministry announced pharma export
target at USD 25 billion by the year 2014. However, Appaji PV,
Director General of Pharmexcil said that to be pragmatic, the
target year could extend to 2016 in light of the global economic
scenario.
Pharmexcil endeavors to set up a warehouse in Nigeria with aid
from the Commerce Ministry, in a move to support trading
communities. This is a first of its kind of measure. The
organization was present at Chennai for announcing "iPHEX
2013"- a three-day pharma road show scheduled to start on 24
April in Mumbai. 250 companies would be part of the show.

6. DIPP looks for details on 3 cancer
drugs for compulsory licensing
Department of Industrial Policy and Promotion (DIPP)
has sought details from the Health Ministry regarding
three medicines sold by multi-nationals Roche and
Bristol-Myers Squibb in India to make them affordable.
Earlier in last month, the Health Ministry had approached
the DIPP for issuance of compulsory licences (CLs) for
three anti-cancer drugs — Trastuzumab, Ixabepilone
and Dasatinib — which are very expensive.
One vial (of 50 ml) of 40 mg trastuzumab costs Rs.1.24
lakh, 60 tablets of 20mg each of dasatinib priced at
Rs.1.17 lakh. Similarly, one vial of 45 mg of ixabepilone
costs Rs.66,430.

7. Conti...
Under the Indian Patents Act, a CL can be issued for a
drug if the medicine is deemed unaffordable by the
government and grants permission to qualified generic
drug makers to manufacture it.
As per the WTO agreement, a CL can be invoked by a
national government allowing a company to produce a
patented product without the consent of the patent owner
in public interest.

8. Bristol-Myers Squibb enters a
collaboration agreement with
Reckitt Benckiser Group plc
Bristol-Myers Squibb Company announced that
it has entered into a three-year collaboration
agreement with Reckitt Benckiser Group plc for
its over-the-counter medicines currently sold
across Latin America, primarily in Mexico and
Brazil.
Under the terms of the collaboration agreement,
Reckitt Benckiser will pay Bristol-Myers Squibb
an upfront payment in the amount of $438
million for the exclusive rights to sell, distribute
and market the following medicines for a three-
year period:

9. Conti...
Picot, an antacid, Tempra, a pain reliever
and fever reducer, Micostatin, an
antifungal, and Graneodin, a cough and
cold medicine, sold primarily in Mexico;
and Dermodex, an anti-rash cream,
Luftal, an anti-gas medicine, and
Naldecon, a cold and flu symptoms
treatment, sold primarily in Brazil.

10. Conti...
During the collaboration term, Bristol-Myers
Squibb will retain responsibility for
manufacturing all of the products covered by the
collaboration (either by itself or through third
party manufacturers), and Reckitt Benckiser will
purchase products from Bristol-Myers Squibb
and pay royalties on product sales during the
term of the collaboration.

11. Novartis collaboration aims to eliminate
rheumatic heart disease (RHD) in
Zambia, Africa
Novartis today announced that it has launched
an effort to eliminate rheumatic heart disease in
Zambia in collaboration with
1)The Lusaka University Teaching Hospital (UTH),
2)The Ministry of Health in Zambia,
3)The Pan-African Cardiology Society and
Massachusetts General Hospital (MGH).

12. Conti...
RHD is a complication of untreated streptococcal
infections in which the valves of the heart are
scarred and eventually degenerate, leading to
heart failure. Eliminated by antibiotic treatment
in most developed nations, in the developing
world an estimated 15 million children suffer
from this debilitating and often fatal disease.

13. Said by Mark C. Fishman, Cardiologist and President
of the Novartis Institutes for BioMedical Research
(NIBR).
The toll of heart failure in young children with
RHD in Zambia is immense, for the patient, their
families, and the nation.
For the past several years Novartis has been
working with colleagues in Lusaka to help,
understand and treat asthma in young children.
Novartis is expanding the collaboration to raise
awareness, educate, and provide antibiotic
therapy to prevent RHD."

14. Conti..
Novartis will use portable
echocardiography machines to evaluate
3,000 children, ages 9-10, in Lusaka-area
public schools.

15. Venus sign exclusive marketing
rights deal for Antibiotic Ajuvant
entity
Venus Remedies Limited, the research based
global pharmaceutical company has accord
exclusive marketing rights for its novel antibiotic
product – POTENTOX to South Africa’s
pharmaceutical giant Adcock in a deal company
announced.
POTENTOX is a research based antibiotic
product of the company protected by patent in
USA and in number of other countries across the
Globe including India, Canada, Australia, New
Zealand, South Korea, South Africa and
Ukraine.

16. Conti...
Adcock will have exclusive marketing rights of
the product in South Africa over the period of 15
year. The product will remain under patent
protection till 2025 in African territory and is
expected to be launched by mid of 2015 after
getting due regulatory approvals.

17. Biocon is eyeing Rs 100 cr in sales in the
next four years from psoriasis drug that it
plans to launch under the brand Alzumab
in the country in the current year.

18. Glenmark Pharma gets USFDA nod
for HIV drug
Glenmark Pharmaceuticals said that the US
Food and Drug Administration has provided
marketing approval to its partner in the US, Salix
Pharmaceuticals Limited, for Crofelemer, which
provides relief to patients with diarrhea HIV and
AIDS on anti-retroviral therapy.

19. US FDA approves Stivarga for
advanced GIST
Gastrointestinal stromal tumours (GIST) is a
tumour in which cancerous cells form in the
tissues of the gastrointestinal tract, part of the
body’s digestive system
The US Food and Drug Administration (US FDA)
expanded the approved use of Stivarga
(Regorafenib) to treat patients with advanced
gastrointestinal stromal tumours (GIST) that
cannot be surgically removed and no longer
respond to other FDA-approved treatments for

20. Conti...
Stivarga is the third drug approved by the FDA
to treat gastrointestinal stromal tumours.
Stivarga was approved in September 2012 to
treat colorectal cancer. It is marketed by Bayer
HealthCare Pharmaceuticals, based in Wayne,
NJ. Gleevec is marketed by East Hanover, NJ-
based Novartis, and Sutent is marketed by New
York City-based Pfizer.

21. THANK YOU !!!