9/20/24, 11:08 AM Strides Begins Biosimilar Filings With Teriparatide :: Generics Bulletin

We use cookies to improve your website experience. To learn about our use of cookies and how you can manage your cookie settings,
please see our Cookie Policy. By continuing to use the website, you consent to our use of cookies.

This copy is for your personal, non-commercial use. For high-quality copies or electronic

reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By Dror Schwartz

Strides Begins Biosimilar Filings With Teriparatide

Expands COVID-19 Ambitions
03 Nov 2020 ANALYSIS

by Vibha Ravi @scripvibha [email protected]

Executive Summary
Strides files for a biosimilar to Eli Lilly’s Forteo (teriparatide) in the EU, marking the beginning of its journey
in the biosimilars segment. Meanwhile, it hopes to enter a manufacturing tie-up with COVID-19 vaccine
players in H2 while also planning a launch of favipiravir in markets outside India.

STRIDES IS BEGINNING ITS BIOSIMILARS FORAY THROUGH STELIS Source: Shutterstock

Strides Pharma Science Limited has set sail on its biosimilars journey with a filing for a rival to Eli Lilly and
Company’s Forteo (teriparatide) in the EU, after which a filing is expected in the US in financial year 2022. The
company’s biosimilar business is housed under subsidiary Stelis Biopharma Pvt Ltd.

With all formulation/process patents on this product having expired in both these regions, the EU market for
teriparatide is around $300m, while the US market is worth $500m, a report by brokerage firm IIFL Securities
estimated.

Gedeon Richter launched a biosimilar teriparatide (available as Terrosa) and Stada introduced its product
Movymia in the EU in August 2019, while Alvogen/Pfenex’s follow-on biologic Bonsity was introduced in the
US in June 2020.

https://generics.citeline.com/GB150397/Strides-Begins-Biosimilar-Filings-With-Teriparatide 1/4
9/20/24, 11:08 AM Strides Begins Biosimilar Filings With Teriparatide :: Generics Bulletin

Having found a partner for teriparatide in the EU and emerging markets, Strides is on the look-out for
potential alliances in the US. Globally, there are only three-four competitors and Stelis is the only company
working on both the reusable as well as the disposable-pen device for the product.

Strides’s stake in Stelis is now nearly 52% and the financials of the latter are expected to be consolidated
with Strides either from Q4 of the current financial year or Q1 of FY22, CEO and managing director R
Ananthanarayanan told Generics Bulletin sister publication Scrip after a management call discussing second-
quarter earnings.

Meanwhile, insulins continue to be a focus area for future growth with demand rising across the world and
access to affordable insulin continuing to be limited.

“Our development is on track, the technology is validated for lispro, glargine and rh-insulin and dosing will
begin for glargine clinical trials in Q3 of FY21 for European markets. In fact, a change in regulation in the US
– which means pre-clinical trials are not required now – has made it even more exciting to be present in the
product as it significantly lowers cost prior to submission,” Ananthanarayanan said.
Biocon and partner Mylan launched their insulin glargine product Semglee at 65% discounted list price in the
US, and though traction has been slow since its launch in end-August, they anticipate momentum going
forward. (Also see "Muted Q2 But Biocon Confident Of Insulin Glargine’s Onward US March" - Generics Bulletin, 26
Oct, 2020.)

Stelis has also onboarded its first contract development and manufacturing client for clinical trial supplies of
a biologic product. With these efforts, Stelis will start contributing revenue from the second half of financial
year 2022 and an EBIDTA break-even is expected in FY23.

Meropenem Approval Seen In May

Meanwhile, the fledgling SteriScience Pharma Pvt. Ltd, set up to develop and market synthetic injectables, is
expected to achieve breakeven earlier than Stelis. A joint venture with Brooks Laboratories Ltd gives the
company a head start via access to carbapenems, which have limited competition.

An EU filing for meropenem has been completed and an approval is expected by May 2021. With eight
generic players already, the size of the global market for meropenem is estimated at $200m. However, other
carbapenems like doripenem don’t have generic competition yet. Shionogi Inc’s US patent 8,247,402 on
doripenem, sold as Doribax, is set to expire in the US on 30 March 2021.

Besides, the transfer of some existing intellectual property assets from Agila Specialties Pvt Ltd that was sold
to Mylan NV in 2013 is expected to propel future filings. (Also see "Strides Readies SteriScience For Injectables
Push" - Generics Bulletin, 18 Sep, 2020.) and (Also see "Strides Plans Re-Entry On Injectables" - Generics Bulletin,
7 Oct, 2019.)

“We have a significant amount of knowledge in the company from our Agila days. These are off-patent
products and out of our non-compete portfolio with Mylan, we are selecting 30 to 50 products that are more
valuable rather than go after the entire market that we have knowledge about. We have already begun work
on a number of products and will be able to start filings soon,” Ananthanarayanan said.

With a strong front-end in the US and Europe, SteriScience intends to market these products primarily in
these markets. Nearly 15 abbreviated new drug applications are expected to be filed during FY22 and
regulatory approvals are expected to “begin flowing” in nine to 10 months.

“By second half of next year, I like to believe that we should be aiming at an operational breakeven in the
combined study SteriScience and Stelis business,” he added.

https://generics.citeline.com/GB150397/Strides-Begins-Biosimilar-Filings-With-Teriparatide 2/4
9/20/24, 11:08 AM Strides Begins Biosimilar Filings With Teriparatide :: Generics Bulletin

The IIFL brokerage report indicated that SteriScience’s injectable launches are expected to begin in the
regulated markets by Q1 FY23 and EBITDA break-even is expected in early FY24.

COVID-19 Vaccine, Favipiravir Ambitions

Strides also expects to commission a vaccine suite for RNA, DNA, protein subunit and viral vector vaccines
around December or January. Given that several global vaccine makers are seeking capacity to manufacture
their vaccines, it will open a host of opportunities, but Ananthanarayanan is keeping his cards close to his
chest.

“We have advanced significantly in talks with global companies…at this time we are not ready to divulge who
those companies are, but we are hoping that by the time our suite is ready in December, we would have
progressed significantly on closure,” he told Scrip.

The Bangalore plant will have high speed filling

lines with annual capacity of 500 million doses of
J&J Taps Biological E For Up To 500m
liquid vaccines and/or 300 million doses of
lyophilized vaccines and given that vaccine Coronavirus Vaccine Doses A Year
developers are looking for manufacturing partners By Vibha Ravi
to fulfil demand for billions of doses of vaccines, a 14 Aug 2020
courtship was to be expected.
Johnson & Johnson has added a manufacturing
Companies like Serum Institute of India and Biological
base in India’s Biological E as part of a global
E Limited have already entered into manufacturing
supply chain for its COVID-19 vaccine candidate.
alliances with AstraZeneca and Johnson & Johnson
While Biological E will make 400-500 million
respectively while others like Aurobindo are building
dosages for the US firm, it has licensed for
capacities to cater to COVID-19 vaccine demand.
development another SARS-CoV-2 vaccine
(Also see "Aurobindo Enters Fray For COVID-19 Vaccine"
candidate from US-based Baylor College of
- Scrip, 17 Aug, 2020.)
Medicine.
The company also plans to tap global markets for Read the full article here ❯
favipiravir after having supplied the product for
clinical studies to certain Gulf Cooperation Council
countries and conducted bioequivalence studies in India with Fujifilm Toyama Chemical’s Avigan as the
reference product. (Also see "Can Avigan Bite Into Buzzing Indian Favipiravir Market?" - Scrip, 20 Aug, 2020.)

“We are also looking at clinical studies on a global basis but it’s too early to give more colour to that,”
Ananthanaranayan said, adding that certain other Strides products like steroids are being used for treatment
of COVID-19 symptoms.

Second Quarter Impacted By COVID-19

Meanwhile, the company’s consolidated operational revenue for the second quarter rose 11% year-on-year
and 1.4% quarter-on-quarter to INR7.93bn ($106.7m). Q2 net profit, however, nearly halved compared to the
previous year, coming in at INR770m, led by higher expenditure and the absence of an exceptional gain that
was reported in Q2 FY20.
Operations were disrupted during the quarter as
over 400 employees tested positive for COVID-19
India Q2 Preview: Glenmark, Cipla Emerge
out of a total workforce of nearly 3,000 across
Indian facilities. With manufacturing suffering Stronger
intermittent shutdown across multiple facilities By Vibha Ravi
including the flagship plant in Bangalore, inventory 20 Oct 2020

https://generics.citeline.com/GB150397/Strides-Begins-Biosimilar-Filings-With-Teriparatide 3/4
9/20/24, 11:08 AM Strides Begins Biosimilar Filings With Teriparatide :: Generics Bulletin

depletions and stockouts in the US led to loss of With the impact of pandemic-prompted disturbances
revenue opportunities and lower order fulfilment in waning, analysts forecast better Q2 numbers for Indian
other regulated markets including Australia. pharma firms, with some including Glenmark and Cipla

Besides, lower footfalls at pharmacies and fewer seen emerging winners. But after doing well in the

surgeries led to lower prescription generation in US quarter, Gilead’s licensees might see remdesivir
and Europe and for the first time, the company demand tapering somewhat in Q3 post the WHO
witnessed price erosion in certain products in the finding the antiviral ineffective in COVID-19
US, though management declined to provide treatment.
specifics. Read the full article here ❯
Ananthanarayanan expressed hope of a strong
rebound in the second half of FY21 as
manufacturing has resumed, the order book for certain regulated markets like Australia remain strong,
inventory is being replenished and product filing momentum is expected to pick up, with over eight ANDA
filings expected in the US and over 10 in other regulated markets during H2.

IIFL Securities, meanwhile, has downgraded the stock from a buy to an add given that Strides has rallied by
over 45% over the past three months and is now trading at price to earnings multiple of 14 times. It also cut
FY21/22 earnings per share estimates by 5% and 2% respectively on the back of higher finance costs. Strides
has invested heavily in Stelis and Steriscience and more investments are foreseen for a few more years.

Hurry! There are 4 days left in your free trial.

To continue your access Generics Bulletin, subscribe today.

SUBSCRIBE

Note: your trial gives you access to the most recent year of content.

https://generics.citeline.com/GB150397/Strides-Begins-Biosimilar-Filings-With-Teriparatide 4/4