In case you haven’t had time to follow the Mylan-Teva, Perrigo-Mylan saga of
the past few weeks, we compiled a quick set of facts for your speed read needs:
Table: Perrigo & Mylan versus Mylan & Teva:
Perrigo
Mylan
Teva
Fast Fact
World’s largest manufacturer of OTC healthcare products for the store brand market
Holds the number one ranking
in the U.S. generics prescription market in terms of sales
Teva is the world’s largest generic medicines producer
Annual Revenues (2014)
$4.06 billion
$7.72 billion
$20.27 billion
Size of their generics business
$927.1 million
$6.46 billion
$9.8 billion
Top products
Tysbari®
Epi-Pen®
Copaxone®
(royalty share: 18% up to $2 billion in sales)
($1 billion)
($4.24 billion)
2013 Acquisitions
DEC-2013: Elan Pharmaceuticals
FEB-2013: Agila Specialties
$9.5 billion
$1.75 billion
(Tax inversion)
2014 Acquisitions
NOV-2014: Omega Pharma $4.5 billion
JUL-2014: Abbott’s non-US generics business $5.3
billion (tax inversion)
SEPT-2014: Arixtra® rights
$300 million
2015 Acquisitions
FEB-2015:
Famy Care
MAR-2015:
Auspex
$800 million
$3.2 billion
April 2015
Perrigo & Mylan
Mylan & Teva
Perrigo has rejected 3 takeover offers
from Mylan.
They first valued Perrigo at just under $29 billion, the next at $33 billion and the last one at $35.6 billion.
Mylan rejected Teva’s unsolicited $40 billion bid for Mylan, 50% in
cash and 50% in stock.
Teva valued Mylan
at $82/share.
If Mylan’s takeover of Perrigo fails, there is a high possibility that Teva, in its quest for growth, will eventually acquire Mylan. However, the highlight of this month long saga, has been the over 3,000 word letter Mylan’s Executive Chairman wrote when rejecting the Teva deal (Mylan internally refers to Teva stock as “toilet paper”).
Mylan’s Board answered that financially, Teva’s offer, does not even come close to qualify as a proposal worth pursuing (starting point of discussion - excess of $100 per share). Other concerns were also cited such as: Mylan having a
substantial business in India, while Teva has a limited presence, and has been disparaging about India’s products and culture. In addition, should the deal come through, the massive overlapping positions would create significant antitrust concerns.
On the other hand, here are some comments from the response of Mylan.
Take your pick on what you think hurt the most:
* “Mylan would give Teva severe indigestion”.
* We believe Teva shares to be “low-quality and high-risk currency”.
* Teva is offering Mylan shareholders to “take stock of a poorly performing troubled company in a combination that lacks industrial logic and is a terrible cultural fit”.
* There is “persistent turnover and turmoil amongst the Teva leadership and Board”, “strategic confusion” and Teva’s under performance is “directly attributed to its “dysfunctional” culture”.
* The Board was described “like a Nuthouse” and ran the only CEO with pharmaceutical experience out of town within 18 months of being on the job
* “Do not wish to make Teva’s problems Mylan’s problems”
Impressions: 5485
Unrelated to the inspection of
the USFDA at the Dr. Reddys Srikakulam facility, Dr. Reddys sought permission from the Ministry of Environment,
Forests & Climate Change to expand
their drug and intermediate manufacturing at three locations.
All three chemical technical operation (CTO) units, CTO-I, CTO-II & CTO-III are located in Medak district and the announced planned capacity increases along with the anticipated capital investment were
Existing Capacity
Planned Capacity
Anticipated Investment
CTO I
14.7 TPM
45.5 TPM
Rs 30 crores
CTO II
21.9 TPM
68.9 TPM
Rs 45 crores
CTO - III
4.45 TPM
28.1 TPM
Rs 12 crores
*$1 million is approximately about Rs 6.2
crores & TPM is tons per month
In addition, the declaration given by Dr. Reddys also mentions the various products which will be produced at each facility (table below).
Needless to say, the plans are ambitious however with the growth witnessed by the Indian pharmaceutical industry over the past decade, one can understand Dr. Reddys commitment to investing further in their business.
Table Dr. Reddys production plans at various facilities
Product
Name
Planned
Capacity (TPM)
Facility
Location
Alendronate
Sodium Trihydrate
6.67
CTO
- III
Alfuzosin
2.33
CTO
- I
Altretamine
0.03
CTO
- I
Amlodipine
Besylate
33.33
CTO
- II
Amlodipine
Besylate
133.33
CTO
- III
Amlodipine
Besylate ( Ethyl 4 [2- (pthalamide)ethoxy] aceto acetate (TDM-2)
100
CTO
- II
Amlodipine
Maleate
30
CTO
- III
Amsacrine
0.07
CTO
- I
Anastrazole
0.83
CTO
- II
Aprepitant
3.33
CTO
- III
Aripiprazole
0.33
CTO
- II
Atomoxetine
1.67
CTO
- III
Atorvastatin
375.83
CTO
- II
Azacitidine
0.67
CTO
- I
Bicalutamide
0.03
CTO
- II
Bivalirudin
0.03
CTO
- II
Bivalirudin
Trifluoro Acetate
0.03
CTO
- I
Bortezomib
0.03
CTO
- I
Cabazitaxel
0.02
CTO
- I
Candesartan
cilexetil
6.67
CTO
- II
Cetirizine
Hydrochloride
66.67
CTO
- I
Cetirizine
16.67
CTO
- II
Ciprofloxacin
176.67
CTO
- II
Ciprofloxacin
HCl
533.33
CTO
- II
Ciprofloxacin Lactate
33.33
CTO
- II
Clopidogrel
Bisulfate
500
CTO
- I
Clopidogrel Premix
166.67
CTO
- II
Diluted
Everolimus 5% (Everolimus)
0.33
CTO
- II
Disodium
Pamidronate
0.33
CTO
- III
Docetaxel
1.9
CTO
- I
Dutasteride
3.33
CTO
- II
Esomeprazole
magnesium
66.67
CTO
- III
Ezetimibe
3.33
CTO
- II
Fexofenadine
Hydrochloride
500
CTO
- I
Finasteride
10
CTO
- II
Fluoxetine
110
CTO
- I
Fondaparinux
Sodium
0.33
CTO
- II
Galantamine
0.03
CTO
- II
Gemcitabine
13.33
CTO
- I
Glimepiride
13.33
CTO
- II
Imatinib
0.17
CTO
- I
Irinotecan
0.33
CTO
- I
Ketorolac
66.67
CTO
- II
Lacidipine
5
CTO
- III
Lamotrigine
33.33
CTO
- I
Lansoprozole
8.33
CTO
- III
Letrozole
0.03
CTO
- II
Levocetrizine
Di HCl
10
CTO
- III
Levofloxacin
200
CTO
- II
Lomustine
1.33
CTO
- I
Losartan
Postassium
150
CTO
- I
Meloxicam
0.03
CTO
- I
Memantine
HCl
3.33
CTO
- II
Mesalamine
0.03
CTO
- II
Metoprolol
Succinate
266.67
CTO
- II
Moxifloxacin
116.67
CTO
- II
Norfloxacin
0.03
CTO
- I
Omeprazole
133.33
CTO
- III
Omeprazole
Magnesium
50
CTO
- III
Omeprazole
Sodium
10
CTO
- III
Omerprazole Form B
33.33
CTO
- III
Paclitaxel
0.33
CTO
- I
Pantoprazole
Sodium
100
CTO
- III
paroxetine
HCl
0.03
CTO
- II
Pemetrexed
0.67
CTO
- I
Rabeprazole
Sodium
83.33
CTO
- III
Raloxifene
33.33
CTO
- II
Ramipril
100
CTO
- III
Repaglinide
6.67
CTO
- II
Rivastigmine
6.67
CTO
- II
Risperidone
13.33
CTO
- I
Rivastigmine
6.667
CTO
- I
Rizatriptan
Benzoate
1.33
CTO
- II
Rocuronium
Bromide
0.03
CTO
- II
Ropinrole
HCl
1.83
CTO
- III
Rosiglitazone
3.33
CTO
- II
Sparfloxacin
3.33
CTO
- I
Tacrolimus
5
CTO
- II
Tadalafil
3.33
CTO
- II
Telmisartan
100
CTO
- II
Temozolamide
0.03
CTO
- I
Terbinafine
HCl
133.33
CTO
- III
Tizanidine
HCl
16.67
CTO
- III
Topotecan
0.07
CTO
- I
valganciclovir
0.03
CTO
- I
Vardenafil
3.33
CTO
- II
Voriconazole
8.33
CTO
- III
Ziprasidone
Hydrochloride
100
CTO
- I
Zoledronic
acid
0.33
CTO
- III
Zolmitriptan
0.83
CTO
- I
Zonisamide
0.03
CTO
- II
Impressions: 3162
A recent study published in the Journal of the American Medical Association (JAMA) showed that patients who received the anticoagulant fondaparinux (Arixtra®) and had experienced a certain type of heart attack had a lower risk of major bleeding events and death, both in the hospital and after six months, compared to patients who received low-molecular-weight heparin (LMWH).
The authors analyzed data from a Swedish registry, which included 40,616 patients who had experienced an NSTEMI (non-ST-segment elevation myocardial infarction). A certain pattern on an electrocardiogram following the heart attack was observed, and 14,791 patients (36.4 percent) received fondaparinux, while 25,825 (63.6 percent) received LMWH.
Fondaparinux, an injectable blood thinner that fights clots in the legs (deep vein thrombosis – DVT) and lungs (pulmonary embolism – PE), is a synthetic pentasaccharide, which is difficult to manufacture on a commercial scale.
Arixtra belonged to GSK as recently as 2013, when it was sold off to the South African company Aspen Global Incorporated. Due to Aspen’s lack of a sales representative in the US, they were forced to enter into a $300 million agreement with Mylan for the US market, through which Mylan would pay Aspen $225 million upon completion of the transaction, and an additional $75 million would be held in escrow until certain conditions were met. Apotex had previously been given the rights to sell the authorized generic of Arixtra, the rights of which would eventually transfer to Mylan, which was scheduled to occur by the end of 2014.
Arixtra and the authorized generic of Arixtra had US sales of approximately $18.8 million and $95.3 million, respectively, for the 12 months ending on June 30, 2014, according to IMS Health.
Currently, the only approved product on the US market, other than Mylan’s, is that of Dr. Reddy’s, which was approved in 2011. Dr. Reddy’s entered into a partnership with the Australian company Alchemia, who claims to have been granted patents over novel synthetic pathways that prevent others from using Alchemia’s proprietary process to manufacture fondaparinux until at least 2022.
The regulatory filing review on PharmaCompass shows two suppliers of the key intermediates who have submitted USDMFs, along with multiple API DMF fillings indicating increased availability of the drug substance. This should overcome a major barrier to entry into the Fondaparinux business.
What makes us believers in Fondaparinux? Here are some facts:
$150 million – This is the size of the market in the United States alone.
There are only 2 approved US marketing authorization holders (Mylan and Dr. Reddy’s).
There are alternative API supply sources emerging other than Aspen (through Sanofi’s Sisteron site and Alchemia).
Blood thinners are a booming opportunity. Pfizer’s Eliquis, Bayer’s Xarelto, and Boehringer Ingelheim’s Pradaxa are all expected to achieve sales of more than $1 billion each.
There has been limited development activity in India as demonstrated by the trade data.
The high development costs will keep this market niche in the long run.
The recently published study data is extremely positive and will increase sales.
Impressions: 5078