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MONTHLY DOSE
DECEMBER 2018
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Schrodinger, Sun Pharma arm announce research pact
Biocon’s after joint product gets approval in EU
Lupin launches generic prostatic hyperplasia treatment drug in US
Investors irked by lack of disclosures at Sun Pharma
Alkem Labs gains after closure of USFDA inspection at St. Louis facility
USFDA makes 22 observations post inspection of Lupin's Mandideep
facilities
Lupin’s Canada arm received an approval from Health Canada for Zaxine
drug
Zydus Wellness to raise Rs2,575cr through share sale to investors
Aurobindo faces US suit over carcinogenic elements in blood pressure
drug
Cipla to acquire South African drug maker Mirren for USD33mn
USFDA recommends regulatory action after Jubilant Life's Roorkee plant
inspection
Biocon's biosimilar chase gets a boost with EU approval for Ogivri
Lupin gets Establishment Inspection Report from USFDA for Pithampur
facility unit
Dr. Reddy's launches heartburn drug in US market
Aurobindo Pharma’s arm to form JV with Shandong Luoxin Pharma
US Court decision delays Dr. Reddy's Suboxone sale
Zydus Wellness gets CCI approval for acquisition of Heinz India
EU court upholds EUR13.96mn fine on Unichem Lab in Perindopril
litigation
USFDA completes Biocon's Telangana plant inspection
Glenmark Pharmaceuticals announces new data on GBR-1302
Alembic Pharma’s Panelav facility clears USFDA inspection
Lupin out-licenses novel blood cancer drug to AbbVie
Torrent Pharma recalls Losartan hypertension tablet in US
Glenmark forays into branded dermatology segment in US
Dr. Reddy's launches anti-coagulant drug in US market
DUSA Pharmaceuticals, Inc. awarded preliminary injunctive relief
prohibiting Biofrontera from using its trade secrets
Dr. Reddy's launches oral suspension drug in the US market
Suven Life gets product patents from Brazil, Eurasia
Cipla recalls 4800 bottles of anti-HIV tablets from American market
Neuland Laboratories received no observation issued by USFDA for its
manufacturing facility
Free Pharma samples come under GST lens
3.36% of about 82,600 drugs tested by drug controllers samples found to
be substandard
Delhi HC orders ban on online sale of medicines by e-pharmacists
across country
ICRA assigns stable outlook for Indian Pharma companies
Rising shipments to US help Indian Pharma exports rebound in H1FY19
Big Pharma returning to US price hikes in January after pause
Industry
Company
Global
News for the Month
Source: Media Reports and Company Press Releases
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Company API Strengths Indications Brand (Company) Mkt Size
Lupin Apixaban 2.5 and 5 mg Managing non valvular atrial
fibrillation
Eliquis (Bristol-Myers
Squibb)
USD6,366mn
Unichem Labs Tadalafil 2.5/5/10/20 mg Treatment of erectile dysfunction Cialis (Eli Lilly) USD1.9bn
Zydus Cadila Pregabalin 25/50/75/100/150/
200/225/300 mg
Used to control seizures, painful
nerve diseases and fibromyalgia
Lyrica (Pfizer) USD5bn
Lupin Tadalafil 20 mg Treatment of pulmonary arterial
hypertension (PAH)
Adcirca (Eli Lilly) USD503.8mn
Zydus Cadila Febuxostat 40/80 mg Used to treat hyper Uricemia Uloric (Takeda) -
Company API Strengths Indications Brand (Company) Mkt Size
Zydus Cadila Teriflunomide 7/14 mg Treat relapsing multiple sclerosis Aubagio (Sanofi Aventis) USD1.6bn
Sun Pharma Ganirelix Acetate
Inj.
250 mcg/0.5 mL Treatment of infertility Ganirelix (Organon) USD67mn
Alembic Pharma Glycopyrrolate 1/2 mg Used as adjunctive therapy in
treatment of peptic ulcer
Robinul & Robinul Forte
(Casper Pharma LLC)
USD15mn
Alembic Pharma Candesartan
Cilexetil
4/8/16 mg Treatment of hypertension Atacand (ANI Pharma) USD22mn
Cipla Montelukast Sodium 4/5mg Treatment of asthma Singulair (Merck) USD90-100mn
Alembic Pharma Olopatadine HCL
ophthalmic solution
0.1% Treat allergic conjunctivitis Patanol (Novartis) USD61mn
Cadila Ranitidine injection 25 mg/mL, 2 mL single dose vials
& 6 mL
multi-dose vials
Treat stomach and duodenal ulcers Zantac (Glaxo) USD412.4mn
Strides Pharma,
Cadila
Albendazole 200 mg Treat infections caused
by tapeworm
Albenza (Amneal
Pharma)
USD100mn
Glenmark Hydrocortisone
Valerate Ointment
0.2% Used to treat skin conditions Westcort (Sun Pharma
Inc.)
USD11.1mn
Lupin Clobazam 10/20 mg Treatment of seizures associated
with Lennox-Gastaut syndrome
Onfi (Lundbeck Pharma) USD601.2mn
Glenmark Fluocinolone
Acetonide Oil
0.01% Treat eczema of the ear DermOtic1 Oil
(Hill Derma)
USD18.1mn
Aurobindo Potassium Chloride 8mEq(600 mg)
&10mEq(750 mg)
Treatment of hypokalemia Klor-Con (Upsher-Smith) USD60mn
Unichem Labs Pramipexole
Dihydrochloride tabs
0.125/0.25/0.5/
0.75/1/1.5 mg
Treat Parkinson's disease & Restless
Legs Syndrome
Mirapex (Boehringer
Ingelheim Pharma)
-
Zydus Cadila Doxycycline Hyclate 75/100/150 mg Treat bacterial infections Vibramycin (Pfizer) USD300mn
Strides Pharma Polyethylene Glycol 3350 & Electrolytes
for Oral Solution
236 /2.97gms,6.74/5.86gms &
22.74gms/4Liter
Laxative GoLYTELY (Braintree
Laboratories)
US400mn
(combined size)
Aurobindo Vecuronium
Bromide Injection
10/20mg Used as part of general anesthesia Norcuron Inj. (Organon) USD11mn
Dr. Reddy Sevalamer
Carbonate
0.8/2.4kg Lower high blood phosphorus
(phosphate) levels
Renvela (Genzyme
Corporation)
USD101mn
Cadila Clindamycin Phosphate and
Benzoyl Peroxide
Gel
1.2%, 5% Treat certain type of acne
(inflammatory acne vulgaris)
Duac (GSK) USD130mn
Tentative ANDA Approvals:
Final ANDA Approvals:
Source: Media Reports and Company Press Releases
Source: Media Reports and Company Press Releases
BSE Health Care Index Price Performance
Companies
Price
Chg (%)
1 M 6 M 12 M
Aarti Drugs Ltd 575 4.5% 4.7% -9.9%
Abbott India Ltd 7519 1.1% 3.8% 36.4%
Ajanta Pharma Ltd 1186 1.8% 20.4% -20.7%
Alembic Ltd 48 10.8% 20.7% -17.4%
Alembic Pharmaceuticals Ltd 598 -3.1% 18.8% 12.5%
Alkem Laboratories Ltd 1946 1.9% 3.1% -11.8%
Apollo Hospitals Enterprise Ltd 1259 -0.3% 20.3% 4.7%
AstraZeneca Pharma India 1452 3.9% 2.4% 23.0%
Aurobindo Pharma Ltd 731 -9.8% 20.5% 6.7%
Biocon Ltd 629 1.1% 1.6% 17.0%
Bliss GVS Pharma Ltd 166 9.9% -1.4% -21.9%
Cadila Healthcare Ltd 348 -4.5% -7.9% -19.7%
Caplin Point Laboratories Ltd 382 -5.1% -10.3% -39.8%
Cipla Ltd 520 -3.7% -15.4% -15.0%
Divi's Laboratories Ltd 1482 3.1% 42.7% 34.9%
Dr Reddy's Laboratories Ltd 2617 -3.6% 17.2% 8.5%
Dr. Lal PathLabs Ltd 913 7.9% -4.4% 3.2%
Eris Lifesciences Ltd 684 10.4% 0.1% -13.1%
FDC Ltd 173 -9.0% -23.3% -30.7%
Fortis Healthcare Ltd 140 -4.9% 4.2% -11.0%
GSK Pharmaceuticals Ltd 1512 11.6% -46.1% -38.5%
Glenmark Pharmaceuticals Ltd 692 5.9% 18.8% 16.2%
Granules India Ltd 90 1.3% 11.4% -34.6%
Gufic Biosciences Ltd 94 9.0% -23.9% -25.5%
HealthCare Global Enterprises Ltd 197 -10.3% -31.0% -29.1%
Hester Biosciences Ltd 1128 -8.5% -13.4% -39.0%
Hikal Ltd 156 3.4% 7.0% -34.1%
Indoco Remedies Ltd 218 4.4% 19.4% -23.4%
Indraprastha Medical Corp. Ltd 39 -0.6% -8.8% -39.2%
IOL Chemicals and Pharma Ltd 166 -2.0% 104.0% 102.6%
IPCA Laboratories Ltd 802 0.7% 15.1% 34.5%
J.B. Chemicals & Pharma Ltd 306 2.8% 18.7% -9.3%
Jubilant Life Sciences Ltd 710 -7.7% 1.6% -8.8%
Kopran Ltd 39 6.3% -26.6% -43.2%
BSE Health Care Index Price Performance
Companies
Price
Chg (%)
1 M 6 M 12 M
Laurus Labs Ltd 380 -1.0% -17.6% -29.6%
Lincoln Pharmaceuticals Ltd 225 -5.7% 7.7% -5.5%
Lupin Ltd 846 -4.4% -6.4% -4.4%
Mangalam Drugs and Organics Ltd 73 1.2% -22.3% -65.0%
Marksans Pharma Ltd 28 -5.6% 5.1% -30.3%
Medicamen Biotech Ltd 433 -5.7% -9.2% -31.6%
Merck Ltd 3084 9.3% 30.2% 133.3%
Morepen Laboratories Ltd 22 0.5% -22.4% -43.6%
Narayana Hrudayalaya Ltd 196 -11.6% -16.6% -34.9%
Natco Pharma Ltd 681 -4.8% -15.3% -31.1%
Nectar Lifesciences Ltd 21 -2.4% -6.6% -48.6%
Neuland Laboratories Ltd 459 -4.2% -28.5% -48.2%
Novartis India Ltd 720 3.9% 7.9% 10.3%
Opto Circuits India Ltd 9 5.2% -38.6% -11.5%
Panacea Biotec Ltd 160 9.2% -29.6% -33.6%
Pfizer Ltd (India) 2848 4.7% 10.7% 39.2%
Piramal Enterprises Ltd 2382 8.3% -6.0% -16.3%
Poly Medicure Ltd 221 2.5% 4.8% -21.3%
RPG Life Sciences Ltd 238 1.5% -31.6% -51.0%
Sanofi India Ltd 6353 3.2% 22.5% 35.4%
Shalby Ltd 147 -6.8% -12.8% -
Shilpa Medicare Ltd 384 0.7% -3.2% -37.9%
SMS Pharmaceuticals Ltd 68 2.7% -4.5% -34.4%
Strides Shasun Ltd 461 -4.9% 17.1% -44.0%
SPARC Ltd 188 -27.8% -49.5% -62.4%
Sun Pharmaceutical Industries Ltd 431 -12.5% -23.2% -24.9%
Suven Life Sciences Ltd 227 -5.9% 9.1% 10.9%
Syngene International Ltd 561 3.8% -7.6% 2.7%
Thyrocare Technologies Ltd 527 -3.3% -8.6% -23.7%
Torrent Pharmaceuticals Ltd 1771 0.1% 26.3% 27.0%
Unichem Laboratories Ltd 191 -6.6% -18.9% -41.8%
Vimta Labs Ltd 314 21.7% 40.2% 87.7%
Vivimed Labs Ltd 37 -3.8% -37.5% -65.2%
Wockhardt Ltd 524 -3.1% -18.0% -43.4%
Source: BSE website; All prices are as on 31st December 2018
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Source: BSE website; All prices are as on 31st December 2018
NIFTY PHARMA COMPANIES
Company
Price
(Rs)
Mcap
(Rsmn)
Chg (%)
1 M 6 M 12 M
Aurobindo Pharma Ltd 731 428269 -9.8% 20.5% 6.7%
Biocon Ltd 629 377340 1.1% 1.6% 17.0%
Cadila Healthcare Ltd 348 355802 -4.5% -7.9% -19.7%
Cipla Ltd 520 418662 -3.7% -15.4% -15.0%
Divi's Laboratories Ltd 1482 393478 3.1% 42.7% 34.9%
Dr. Reddy's Laboratories Ltd 2617 434189 -3.6% 17.2% 8.5%
Glenmark Pharmaceuticals Ltd 692 195331 5.9% 18.8% 16.2%
Lupin Ltd 846 382281 -4.4% -6.4% -4.4%
Piramal Enterprises Ltd 2382 429385 8.3% -6.0% -16.3%
Sun Pharmaceutical Industries Ltd 431 1033269 -12.5% -23.2% -24.9%
The year 2018 had been quite eventful for the overall Pharma sector with strategic M&A deals, observations and good number of
tentative and final approvals.
Mergers & Acquisitions (M&A): Going ahead with the objective to
increase its footprints in US; Aurobindo Pharma bought the dermatology
business along with generic oral solid portfolio of Sandoz worth USD900mn
plus USD0.1bn of potential earn-outs. Further, to strengthen its presence in
Eastern Europe markets, it entered into a definitive agreement with Canadian
pharmaceutical firm Apotex to take over its commercial operations in five
European countries.
Zydus Wellness jointly with Cadila Healthcare acquired brands namely
Complan, Glucon-D energy drink and Nycil talcum powder from its owner
Heinz India for USD630mn.
Major Observations: In the year which saw most companies coming out of
regulatory trouble, Lupin got a shocker with USFDA issuing 22 observations at Mandideep, 5 observations at Pithampur and 1
observation at Tarapur facilities. With DRL being no exception, it received 8 observations at Duvvada facility with 5 of them being
repeat of 2017 including a warning letter of 2015.
Ramp up in Approvals: The year that went by saw the highest number of drug approvals of 971 drugs by USFDA as compared to
937 approvals (763 final approvals) last year. This includes 781 Final nods (763 final approvals last year) and 190 Tentative
go-aheads with Indian firms accounting for 35-40% of Global nods.
Sun Pharma Issue: On December 3, Sun Pharma shares witnessed a double-digit fall after a report of questionable corporate
governance practices and a whistle blower complaint to SEBI. Given the weightage of Sun Pharma, the market value destruction of
the company led to the dip in the overall Pharma Index.
For 2018, the sector had experienced volatility throughout, an assorted and action packed year indeed. There was all from
observations to approvals, mergers & acquisitions to the pricing pressure witnessed across the key markets. Going into 2019, we
feel the sector should be a part of investment discussions. The trend of USFDA approvals should continue for most of the key
players. Domestic formulations market would be a key to watch. Since, this is an election year we should expect focus on
healthcare by the government, leading to a further impetus to the growth in the sector. Overall, without much of external factors
affecting the growth, the sector should provide decent returns to investments.
Source: NSE website, Company Research; All prices are as on 31st December 2018
Approvals in the Industry Trends across the Approvals:
Source: USFDA Source: USFDA
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