Infertility

In Vitro Fertilisation (IVF) - a booming market

•    Infertility affects 20% of all couples
•    1 million IVF stimulations globally per year
•    2 to 3 months of daily painful self-injections by each patient
•    $2B IVF hormone market, annual growth >10%
     - Europe: Average cost EUR 5’000 per stimulation plus EUR 1’000-2’000
       hormone costs
     - USA: 400 registered fertility clinics, 120’000 stimulations at a cost of $12’000 each
     - Japan: Self injections critical: demand for alternatives

Detailed Strategy IVF-Hormone Therapy - focus area

Background
An increasing number of couples have problems with infertility. Amongst many reasons for this phenomenon is the fact that couples plan to have babies past their thirties or even forties. Stress and environmental effects complement the difficulties. As a consequence In Vitro Fertilisation techniques are booming and a recent study states that 1-2% of newborns in Austria are IVF-babies. In Denmark the figure is 6.2% (Zech 2005). Europe leads the IVF market with 60% of all worldwide procedures. In Germany almost 90.000 stimulations took place in 2004 (German healthcare statistics report).

IVF-procedure
During a typical IVF- stimulation cycle (resembling the menstrual cycle), women have to administer several hormones by self-injection. Triptorelin, a hormone to down-regulate the specific hormonal activities is injected subcutaneously (s.c.) 10 days before menstruation until the onset of menstruation. After the menstruation, daily FSH (follicle stimulating hormone)  injection will be given in order to induce follicle growth. On day 13, the follicles should be ready for "harvesting", and after ultrasound checks by the gynaecologist, ovulation is induced by a one time injection of HCG-hormone. The egg is extracted 1-2 days after ovulation induction by the gynaecologist, and further processed for in vitro fertilisation. While IVF takes place outside the body, the patient starts daily intramuscular (i.m.) progesterone hormone injections for several weeks in order to prepare the endometrium for the implantation of the fertilised egg, and further to conserve pregnancy. After 3 to 5 days ex vivo the fertilised egg is transplanted back into the uterus, with the goal to settle nicely into the endometrium, where it has to stay in order to develop the embryo. Progesterone is currently administered intramuscularly until heart activity of the embryo is detected (ca. 4 weeks after fertilisation). After that it is the doctors judgement to decide whether progesterone is continued. In the case of multiple pregnancies progesterone will be administered for at least 8-12 weeks and in some cases until labour. Commonly the gynaecologist prescribes i.m. injections until the heart activity has started, and from then onwards progesterone is applied vaginally (less accurate bio-availability).

New product innovation
During the IVF procedure the patients have to self inject several IVF hormone drugs on a daily basis over 5-8 weeks. Injections have to be administered subcutaneously and intramuscularly, which is very cumbersome and painful for most women.
It is Pantec Biosolutions goal to replace the tedious daily injections by intraepidermal patches. The hormones Triptorelin, FSH and progesterone are not suitable for passive intraepidermal patches, because the size and physicochemical nature of the molecules prevent permeation. In all three cases the stratum corneum is the limiting layer. In the case of the larger FSH and Triptorelin also the epidermis will partly hinder transport.  After laser poration of the skin the 3 molecules should permeate into the epidermis and down to the dermis where the drug molecules are taken up by the blood capillaries to enter the systemic circulation.
In vitro feasibility studies show promising results allowing permeation of FSH and progesterone in the double-digit percentage range. These results  have led to the foundation of Pantec Biosolutions AG and to a first collaboration with a Pharmaceutical company with a focus on IVF.